<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02972892</url>
  </required_header>
  <id_info>
    <org_study_id>123.07-2015-GES-0002</org_study_id>
    <nct_id>NCT02972892</nct_id>
  </id_info>
  <brief_title>Multi-site Anesthesia Randomized Controlled STudy of End Tidal Control Compared to Conventional Anesthesia Results</brief_title>
  <official_title>Multi-site Anesthesia Randomized Controlled STudy of End Tidal Control (Et Control) Compared to Conventional Anesthesia Results (MASTER-Anesthesia Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GE Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GE Healthcare</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a clinical, single blind, randomized, prospective research study. The purpose of this&#xD;
      pivotal study is to collect and analyze data on the investigational End tidal Control (Et&#xD;
      Control) option feature. To demonstrate that End tidal Control (Et Control) performance is&#xD;
      non-inferior to conventional anesthesia practice in an adult surgery population by comparing&#xD;
      the performance of the Et Control Arm (investigational arm) to the Control Arm (fresh gas&#xD;
      mode).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this pivotal study is to demonstrate that End tidal Control performance is&#xD;
      non-inferior to conventional anesthesia practice in an adult surgery population, and support&#xD;
      a marketing application in the U.S. for clearance of this feature.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 9, 2017</start_date>
  <completion_date type="Actual">September 5, 2018</completion_date>
  <primary_completion_date type="Actual">September 5, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Duration Without Large Deviation of End-Tidal Anesthetic Agent (EtAA) Based on Extraction Algorithm (ALG)</measure>
    <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
    <description>Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Steady state concentration is based on an extraction algorithm described in Appendix 2 of the protocol.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Duration Without Large Deviation of EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</measure>
    <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
    <description>Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Data obtained using the clinicians' or Investigators' recorded target (TGT) values of anesthetic agent and oxygen for the Control Arm and using the set target values for the Et Control Arm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Duration Without Large Deviation of End-Tidal Oxygen (EtO2) Based on Extraction Algorithm (ALG)</measure>
    <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
    <description>Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Duration Without Large Deviation of EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</measure>
    <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
    <description>Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Values based on clinicians' or Investigators' recorded target values (TGT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy Response Time EtAA Based on Extraction Algorithm (ALG)</measure>
    <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
    <description>Response time: time to reach 90% of the desired change in EtAA steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Response Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</measure>
    <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
    <description>time to reach 90% of the desired change in EtAA and EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy Response Time for EtO2 Based on Extraction Algorithm (ALG)</measure>
    <time_frame>Duration of each steady state, an average of approximately 60 minutes.</time_frame>
    <description>Response time: time to reach 90% of the desired change in EtO2 steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Response Time for EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</measure>
    <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
    <description>Response time: time to reach 90% of the desired change in EtAA and EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Settling Time for EtAA Based on the Extraction Algorithm (ALG)</measure>
    <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
    <description>Settling time: time to achieve the desired EtAA steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Settling Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</measure>
    <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
    <description>Settling time: time to achieve the desired EtAA steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Settling Time for EtO2 Based on the Extraction Algorithm (ALG)</measure>
    <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
    <description>Settling time: time to achieve the desired EtO2 steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Settling Time for EtO2 Based on Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</measure>
    <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
    <description>time to achieve the desired EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Overshoot Amount of the Desired EtAA Based on Extraction Algorithm (ALG)</measure>
    <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
    <description>Overshoot amount of the desired EtAA from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Overshoot Amount of the Desired EtAA Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</measure>
    <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
    <description>Overshoot amount of the desired EtAA from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on clinicians' or Investigators' recorded values (TGT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Overshoot Amount of Desired EtO2 Amount Based on the Extraction Algorithm (ALG)</measure>
    <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
    <description>Overshoot amount of the desired EtO2 from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Overshoot Amount of Desired EtO2 Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</measure>
    <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
    <description>Overshoot amount of the desired EtO2 from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on clinicians' or Investigators' recorded values (TGT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of Et Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG)</measure>
    <time_frame>Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)</time_frame>
    <description>Accuracy of Et Control in maintaining EtAA control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. The accuracy measures include absolute difference between steady state and set EtAA concentrations. The acceptable limits defined by the primary endpoint were: 0.1% of Isoflurane, 0.2% for Sevoflurane, 0.6% for Desflurane. As a measure of Absolute Difference between Steady State and Set EtAA Concentration (%). Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of ET Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</measure>
    <time_frame>Duration of Surgery</time_frame>
    <description>Accuracy of ET Control in maintatining EtAA between user set target and settling end tidal concentrations. Calculated for ET Control arm only. The accuracy measures include absolute difference between steady state and set EtAA concentrations. The acceptable limits defined by the primary endpoint were: 0.1% of Isoflurane, 0.2% for Sevoflurane, 0.6% for Desflurane. Values based on clinicians' or Investigators' recorded values (TGT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG)</measure>
    <time_frame>Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)</time_frame>
    <description>Accuracy of Et Control in maintaining EtO2 control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. outcome measures the absolute difference between Steady State and Set EtO2 Concentrations. The acceptable limit defined by the primary endpoint was &lt; 5% v/v. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</measure>
    <time_frame>Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)</time_frame>
    <description>Accuracy of Et Control in maintaining EtO2 control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. outcome measures the absolute difference between Steady State and Set EtO2 Concentrations. The acceptable limit defined by the primary endpoint was &lt; 5% v/v. Values based on clinicians' or Investigators' recorded values (TGT).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Inhaled Anesthetic Agent</measure>
    <time_frame>Duration of Procedure</time_frame>
    <description>Usage of inhaled anesthetic agent</description>
  </other_outcome>
  <other_outcome>
    <measure>User Interactions</measure>
    <time_frame>Duration of Procedure</time_frame>
    <description>Number of user interactions</description>
  </other_outcome>
  <other_outcome>
    <measure>Discharge From the Operating Room</measure>
    <time_frame>End of surgery to time of last breath</time_frame>
    <description>Time to discharge from the operating room</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">248</enrollment>
  <condition>Et Control Performance in Adult Population Surgery</condition>
  <arm_group>
    <arm_group_label>Et Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Et Control Feature</intervention_name>
    <description>Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
    <arm_group_label>Et Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional Fresh Gas</intervention_name>
    <description>Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
    <arm_group_label>Control Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female 18 years old or greater.&#xD;
&#xD;
          2. Scheduled to undergo general inhaled anesthesia that can be safely exposed to 100%&#xD;
             oxygen for up to 2 minutes during general anesthesia.&#xD;
&#xD;
          3. Expected to have airway secured with laryngeal mask airway (LMA) or endotracheal tube.&#xD;
&#xD;
          4. Undergoing a surgical procedure that is anticipated by the investigator to take&#xD;
             greater than or equal to 1 hour (operative time measured from induction to cessation&#xD;
             of general inhalation anesthetic).&#xD;
&#xD;
          5. American Society of Anesthesiologists (ASA) status classification system I through&#xD;
             III:&#xD;
&#xD;
               1. ASA Physical Status 1 = a normal healthy patient&#xD;
&#xD;
               2. ASA Physical Status 2 = a patient with mild systemic disease&#xD;
&#xD;
               3. ASA Physical Status 3 = a patient with severe systemic disease&#xD;
&#xD;
          6. Undergoing intravenous induction.&#xD;
&#xD;
          7. Ability to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have emergency medical condition requiring surgery.&#xD;
&#xD;
          2. Are female subjects, who are pregnant or lactating.&#xD;
&#xD;
          3. Any subject undergoing cardiac bypass surgery.&#xD;
&#xD;
          4. Any subject undergoing open chest surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melinda Seering, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa Healthcare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loma Linda University</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Healthcare</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <results_first_submitted>April 19, 2022</results_first_submitted>
  <results_first_submitted_qc>October 5, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 2, 2022</results_first_posted>
  <disposition_first_submitted>November 4, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>October 5, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">November 2, 2022</disposition_first_posted>
  <last_update_submitted>October 5, 2022</last_update_submitted>
  <last_update_submitted_qc>October 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data to be shared and reviewed are: adverse events listing, serious adverse event (SAE)/unanticipated adverse device effects (UADE) summary, demographics, surgical procedure, treatment allocation, early termination, critical protocol deviations, device malfunction reports, and plotted data (Et Control subjects with adverse events only). These items are listed in the Data Safety Monitoring Board (DSMB) Charter.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be available according to the following timeline: (1) when a minimum of 20 Et Control subjects enrolled and at least 2 sites initiated and enrolling; (2) 50% enrollment; (3) 80% enrollment; and (4) 100% enrollment.</ipd_time_frame>
    <ipd_access_criteria>Members of the DSMB will have access to the data listed under the Plan Description section. Reports will consist of tables, listings, and figures; and will be delivered electronically at least 7 calendar days prior to the date of each DSMB meeting.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 2, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT02972892/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Enrollment began in June 2017 and was completed in July 2018. 248 subjects were enrolled at 4 sites. Males and females,18 years or older and scheduled to undergo general inhaled anesthesia during surgery, were screened for enrollment into this study. Subjects enrolled were randomized at a 1:1 ratio to either the Et Control Arm or the Control Arm. Randomization was stratified based on the Investigator, subject's pre-existing hypertension status, and subject's ASA status classification.</recruitment_details>
      <pre_assignment_details>Subjects are considered enrolled at the time of informed consent. After consent, subjects were screened against the inclusion/exclusion criteria according to standard procedures of the investigational site.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Et Control</title>
          <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.&#xD;
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
        </group>
        <group group_id="P2">
          <title>Control Arm</title>
          <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.&#xD;
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="110"/>
                <participants group_id="P2" count="118"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="116"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent to treat population included all randomized subjects</population>
      <group_list>
        <group group_id="B1">
          <title>Et Control</title>
          <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.&#xD;
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
        </group>
        <group group_id="B2">
          <title>Control Arm</title>
          <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.&#xD;
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="110"/>
            <count group_id="B2" value="118"/>
            <count group_id="B3" value="228"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="91"/>
                    <measurement group_id="B3" value="181"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="105"/>
                    <measurement group_id="B3" value="203"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="158"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Not an option on the CRF</measurement>
                    <measurement group_id="B2" value="NA">Not an option on the CRF</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="110"/>
                    <measurement group_id="B2" value="118"/>
                    <measurement group_id="B3" value="228"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Duration Without Large Deviation of End-Tidal Anesthetic Agent (EtAA) Based on Extraction Algorithm (ALG)</title>
        <description>Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Steady state concentration is based on an extraction algorithm described in Appendix 2 of the protocol.</description>
        <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
        <population>Intent-to-treat population includes all randomized subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Et Control</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.&#xD;
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.&#xD;
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Duration Without Large Deviation of End-Tidal Anesthetic Agent (EtAA) Based on Extraction Algorithm (ALG)</title>
          <description>Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Steady state concentration is based on an extraction algorithm described in Appendix 2 of the protocol.</description>
          <population>Intent-to-treat population includes all randomized subjects</population>
          <units>percent duration</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.7" spread="10.82"/>
                    <measurement group_id="O2" value="80.8" spread="17.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.</non_inferiority_desc>
            <p_value>&lt;.001</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>10.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.89</ci_lower_limit>
            <ci_upper_limit>15.01</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Duration Without Large Deviation of EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
        <description>Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Data obtained using the clinicians' or Investigators' recorded target (TGT) values of anesthetic agent and oxygen for the Control Arm and using the set target values for the Et Control Arm.</description>
        <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
        <population>Intent-to-treat population includes all randomized subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Et Control</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.&#xD;
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.&#xD;
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Duration Without Large Deviation of EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
          <description>Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Data obtained using the clinicians' or Investigators' recorded target (TGT) values of anesthetic agent and oxygen for the Control Arm and using the set target values for the Et Control Arm.</description>
          <population>Intent-to-treat population includes all randomized subjects</population>
          <units>percent duration</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.0" spread="2.05"/>
                    <measurement group_id="O2" value="45.9" spread="31.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.</non_inferiority_desc>
            <p_value>&lt;.001</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>52.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>46.25</ci_lower_limit>
            <ci_upper_limit>57.95</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Duration Without Large Deviation of End-Tidal Oxygen (EtO2) Based on Extraction Algorithm (ALG)</title>
        <description>Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
        <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
        <population>Intent-to-treat population includes all randomized subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Et Control</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.&#xD;
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.&#xD;
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Duration Without Large Deviation of End-Tidal Oxygen (EtO2) Based on Extraction Algorithm (ALG)</title>
          <description>Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
          <population>Intent-to-treat population includes all randomized subjects</population>
          <units>percent duration</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.1" spread="2.76"/>
                    <measurement group_id="O2" value="92.8" spread="14.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.</non_inferiority_desc>
            <p_value>&lt;.001</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>5.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.64</ci_lower_limit>
            <ci_upper_limit>8.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Duration Without Large Deviation of EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
        <description>Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Values based on clinicians' or Investigators' recorded target values (TGT)</description>
        <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
        <population>Intent-to-treat population includes all randomized subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Et Control</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.&#xD;
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.&#xD;
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Duration Without Large Deviation of EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
          <description>Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Values based on clinicians' or Investigators' recorded target values (TGT)</description>
          <population>Intent-to-treat population includes all randomized subjects</population>
          <units>percent duration</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.8" spread="1.49"/>
                    <measurement group_id="O2" value="41.0" spread="40.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.</non_inferiority_desc>
            <p_value>&lt;.001</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>44.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>35.56</ci_lower_limit>
            <ci_upper_limit>53.41</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy Response Time EtAA Based on Extraction Algorithm (ALG)</title>
        <description>Response time: time to reach 90% of the desired change in EtAA steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
        <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
        <population>Intent-to-treat population includes all randomized subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Et Control</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.&#xD;
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.&#xD;
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy Response Time EtAA Based on Extraction Algorithm (ALG)</title>
          <description>Response time: time to reach 90% of the desired change in EtAA steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
          <population>Intent-to-treat population includes all randomized subjects</population>
          <units>Seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>steady states</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>steady states</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="283"/>
                <count group_id="O2" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73" spread="174.1"/>
                    <measurement group_id="O2" value="196" spread="378.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy: Response Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
        <description>time to reach 90% of the desired change in EtAA and EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).</description>
        <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
        <population>Intent-to-treat population includes all randomized subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Et Control</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.&#xD;
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.&#xD;
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy: Response Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
          <description>time to reach 90% of the desired change in EtAA and EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).</description>
          <population>Intent-to-treat population includes all randomized subjects</population>
          <units>Seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>steady states</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>steady states</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="520"/>
                <count group_id="O2" value="281"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23" spread="40.9"/>
                    <measurement group_id="O2" value="196" spread="455.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy Response Time for EtO2 Based on Extraction Algorithm (ALG)</title>
        <description>Response time: time to reach 90% of the desired change in EtO2 steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
        <time_frame>Duration of each steady state, an average of approximately 60 minutes.</time_frame>
        <population>Intent-to-treat population includes all randomized subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Et Control</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.&#xD;
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.&#xD;
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy Response Time for EtO2 Based on Extraction Algorithm (ALG)</title>
          <description>Response time: time to reach 90% of the desired change in EtO2 steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
          <population>Intent-to-treat population includes all randomized subjects</population>
          <units>Seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>steady states</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>steady states</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="238"/>
                <count group_id="O2" value="318"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93" spread="77.3"/>
                    <measurement group_id="O2" value="246" spread="346.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy: Response Time for EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
        <description>Response time: time to reach 90% of the desired change in EtAA and EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).</description>
        <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
        <population>Intent-to-treat population includes all randomized subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Et Control</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.&#xD;
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.&#xD;
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy: Response Time for EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
          <description>Response time: time to reach 90% of the desired change in EtAA and EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).</description>
          <population>Intent-to-treat population includes all randomized subjects</population>
          <units>Seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>steady states</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>steady states</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="240"/>
                <count group_id="O2" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="129" spread="451.7"/>
                    <measurement group_id="O2" value="406" spread="727.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy: Settling Time for EtAA Based on the Extraction Algorithm (ALG)</title>
        <description>Settling time: time to achieve the desired EtAA steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
        <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
        <population>Intent-to-treat population includes all randomized subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Et Control</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.&#xD;
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.&#xD;
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy: Settling Time for EtAA Based on the Extraction Algorithm (ALG)</title>
          <description>Settling time: time to achieve the desired EtAA steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
          <population>Intent-to-treat population includes all randomized subjects</population>
          <units>Seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>steady states</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>steady states</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="283"/>
                <count group_id="O2" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105" spread="181.9"/>
                    <measurement group_id="O2" value="165" spread="186.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy: Settling Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
        <description>Settling time: time to achieve the desired EtAA steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).</description>
        <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
        <population>Intent-to-treat population includes all randomized subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Et Control</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.&#xD;
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.&#xD;
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy: Settling Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
          <description>Settling time: time to achieve the desired EtAA steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).</description>
          <population>Intent-to-treat population includes all randomized subjects</population>
          <units>Seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>steady states</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>steady states</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="520"/>
                <count group_id="O2" value="281"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23" spread="40.9"/>
                    <measurement group_id="O2" value="196" spread="455.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy: Settling Time for EtO2 Based on the Extraction Algorithm (ALG)</title>
        <description>Settling time: time to achieve the desired EtO2 steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
        <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
        <population>Intent-to-treat population includes all randomized subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Et Control</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.&#xD;
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.&#xD;
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy: Settling Time for EtO2 Based on the Extraction Algorithm (ALG)</title>
          <description>Settling time: time to achieve the desired EtO2 steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
          <population>Intent-to-treat population includes all randomized subjects</population>
          <units>Seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>steady states</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>steady states</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="238"/>
                <count group_id="O2" value="318"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123" spread="117.5"/>
                    <measurement group_id="O2" value="235" spread="213.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy: Settling Time for EtO2 Based on Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
        <description>time to achieve the desired EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).</description>
        <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
        <population>Intent-to-treat population includes all randomized subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Et Control</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.&#xD;
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.&#xD;
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy: Settling Time for EtO2 Based on Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
          <description>time to achieve the desired EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).</description>
          <population>Intent-to-treat population includes all randomized subjects</population>
          <units>Seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>steady states</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>steady states</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="240"/>
                <count group_id="O2" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="167" spread="121.1"/>
                    <measurement group_id="O2" value="815" spread="1327.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy: Overshoot Amount of the Desired EtAA Based on Extraction Algorithm (ALG)</title>
        <description>Overshoot amount of the desired EtAA from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
        <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
        <population>Intent-to-treat population includes all randomized subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Et Control</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.&#xD;
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.&#xD;
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy: Overshoot Amount of the Desired EtAA Based on Extraction Algorithm (ALG)</title>
          <description>Overshoot amount of the desired EtAA from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
          <population>Intent-to-treat population includes all randomized subjects</population>
          <units>percent to mean</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>steady states</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>steady states</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="283"/>
                <count group_id="O2" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.85" spread="12.026"/>
                    <measurement group_id="O2" value="6.54" spread="13.576"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy: Overshoot Amount of the Desired EtAA Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
        <description>Overshoot amount of the desired EtAA from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on clinicians' or Investigators' recorded values (TGT).</description>
        <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
        <population>Intent-to-treat population includes all randomized subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Et Control</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.&#xD;
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.&#xD;
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy: Overshoot Amount of the Desired EtAA Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
          <description>Overshoot amount of the desired EtAA from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on clinicians' or Investigators' recorded values (TGT).</description>
          <population>Intent-to-treat population includes all randomized subjects</population>
          <units>percent to mean</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>steady states</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>steady states</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="519"/>
                <count group_id="O2" value="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.28" spread="6.953"/>
                    <measurement group_id="O2" value="12.09" spread="27.085"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy: Overshoot Amount of Desired EtO2 Amount Based on the Extraction Algorithm (ALG)</title>
        <description>Overshoot amount of the desired EtO2 from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
        <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
        <population>Intent-to-treat population includes all randomized subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Et Control</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.&#xD;
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.&#xD;
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy: Overshoot Amount of Desired EtO2 Amount Based on the Extraction Algorithm (ALG)</title>
          <description>Overshoot amount of the desired EtO2 from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
          <population>Intent-to-treat population includes all randomized subjects</population>
          <units>percent to mean</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>steady states</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>steady states</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="238"/>
                <count group_id="O2" value="318"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.47" spread="8.238"/>
                    <measurement group_id="O2" value="2.80" spread="11.373"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy: Overshoot Amount of Desired EtO2 Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
        <description>Overshoot amount of the desired EtO2 from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on clinicians' or Investigators' recorded values (TGT).</description>
        <time_frame>Duration of each steady state, an average of approximately 60 minutes</time_frame>
        <population>Intent-to-treat population includes all randomized subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Et Control</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.&#xD;
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.&#xD;
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy: Overshoot Amount of Desired EtO2 Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
          <description>Overshoot amount of the desired EtO2 from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on clinicians' or Investigators' recorded values (TGT).</description>
          <population>Intent-to-treat population includes all randomized subjects</population>
          <units>percent to mean</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>steady states</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>steady states</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="240"/>
                <count group_id="O2" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.14" spread="6.277"/>
                    <measurement group_id="O2" value="11.13" spread="20.662"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Accuracy of Et Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG)</title>
        <description>Accuracy of Et Control in maintaining EtAA control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. The accuracy measures include absolute difference between steady state and set EtAA concentrations. The acceptable limits defined by the primary endpoint were: 0.1% of Isoflurane, 0.2% for Sevoflurane, 0.6% for Desflurane. As a measure of Absolute Difference between Steady State and Set EtAA Concentration (%). Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
        <time_frame>Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)</time_frame>
        <population>Subjects randomized to the ET control arm of the study who underwent surgery</population>
        <group_list>
          <group group_id="O1">
            <title>ET Control - Desflurane</title>
            <description>Subjects randomized to the ET Control arm of the trial who received Desflurane as their inhaled anesthetic agent.</description>
          </group>
          <group group_id="O2">
            <title>Et Control - Isoflurane</title>
            <description>Subjects randomized to the ET Control arm of the trial who received Isoflurane as their inhaled anesthetic agent.</description>
          </group>
          <group group_id="O3">
            <title>ET Control - Sevoflurane</title>
            <description>Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.</description>
          </group>
          <group group_id="O4">
            <title>ET Control - All</title>
            <description>Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.</description>
          </group>
        </group_list>
        <measure>
          <title>Accuracy of Et Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG)</title>
          <description>Accuracy of Et Control in maintaining EtAA control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. The accuracy measures include absolute difference between steady state and set EtAA concentrations. The acceptable limits defined by the primary endpoint were: 0.1% of Isoflurane, 0.2% for Sevoflurane, 0.6% for Desflurane. As a measure of Absolute Difference between Steady State and Set EtAA Concentration (%). Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
          <population>Subjects randomized to the ET control arm of the study who underwent surgery</population>
          <units>Absolute Difference (%)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>steady states</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="100"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>steady states</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="178"/>
                <count group_id="O4" value="282"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.056"/>
                    <measurement group_id="O2" value="0.04" spread="0.031"/>
                    <measurement group_id="O3" value="0.04" spread="0.026"/>
                    <measurement group_id="O4" value="0.05" spread="0.043"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Accuracy of ET Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
        <description>Accuracy of ET Control in maintatining EtAA between user set target and settling end tidal concentrations. Calculated for ET Control arm only. The accuracy measures include absolute difference between steady state and set EtAA concentrations. The acceptable limits defined by the primary endpoint were: 0.1% of Isoflurane, 0.2% for Sevoflurane, 0.6% for Desflurane. Values based on clinicians' or Investigators' recorded values (TGT).</description>
        <time_frame>Duration of Surgery</time_frame>
        <population>Subjects Randomized to the ET control arm of the study who underwent surgery</population>
        <group_list>
          <group group_id="O1">
            <title>ET Control - Desflurane</title>
            <description>Subjects randomized to the ET Control arm of the trial who received Desflurane as their inhaled anesthetic agent.</description>
          </group>
          <group group_id="O2">
            <title>Et Control - Isoflurane</title>
            <description>Subjects randomized to the ET Control arm of the trial who received Isoflurane as their inhaled anesthetic agent.</description>
          </group>
          <group group_id="O3">
            <title>ET Control - Sevoflurane</title>
            <description>Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.</description>
          </group>
          <group group_id="O4">
            <title>ET Control - All</title>
            <description>Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.</description>
          </group>
        </group_list>
        <measure>
          <title>Accuracy of ET Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
          <description>Accuracy of ET Control in maintatining EtAA between user set target and settling end tidal concentrations. Calculated for ET Control arm only. The accuracy measures include absolute difference between steady state and set EtAA concentrations. The acceptable limits defined by the primary endpoint were: 0.1% of Isoflurane, 0.2% for Sevoflurane, 0.6% for Desflurane. Values based on clinicians' or Investigators' recorded values (TGT).</description>
          <population>Subjects Randomized to the ET control arm of the study who underwent surgery</population>
          <units>Absolute Difference (%)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>steady states</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="100"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>steady states</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="72"/>
                <count group_id="O3" value="362"/>
                <count group_id="O4" value="519"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="0.054"/>
                    <measurement group_id="O2" value="0.03" spread="0.031"/>
                    <measurement group_id="O3" value="0.04" spread="0.027"/>
                    <measurement group_id="O4" value="0.05" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG)</title>
        <description>Accuracy of Et Control in maintaining EtO2 control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. outcome measures the absolute difference between Steady State and Set EtO2 Concentrations. The acceptable limit defined by the primary endpoint was &lt; 5% v/v. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
        <time_frame>Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)</time_frame>
        <population>Subjects randomized to the ET control arm of the study who underwent surgery.</population>
        <group_list>
          <group group_id="O1">
            <title>ET Control - Desflurane</title>
            <description>Subjects randomized to the ET Control arm of the trial who received Desflurane as their inhaled anesthetic agent.</description>
          </group>
          <group group_id="O2">
            <title>Et Control - Isoflurane</title>
            <description>Subjects randomized to the ET Control arm of the trial who received Isoflurane as their inhaled anesthetic agent.</description>
          </group>
          <group group_id="O3">
            <title>ET Control - Sevoflurane</title>
            <description>Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.</description>
          </group>
          <group group_id="O4">
            <title>ET Control - All</title>
            <description>Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.</description>
          </group>
        </group_list>
        <measure>
          <title>Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG)</title>
          <description>Accuracy of Et Control in maintaining EtO2 control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. outcome measures the absolute difference between Steady State and Set EtO2 Concentrations. The acceptable limit defined by the primary endpoint was &lt; 5% v/v. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).</description>
          <population>Subjects randomized to the ET control arm of the study who underwent surgery.</population>
          <units>Absolute Difference (%)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>steady states</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="100"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>steady states</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="146"/>
                <count group_id="O4" value="238"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.57" spread="0.594"/>
                    <measurement group_id="O2" value="0.62" spread="0.613"/>
                    <measurement group_id="O3" value="0.64" spread="0.932"/>
                    <measurement group_id="O4" value="0.62" spread="0.818"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
        <description>Accuracy of Et Control in maintaining EtO2 control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. outcome measures the absolute difference between Steady State and Set EtO2 Concentrations. The acceptable limit defined by the primary endpoint was &lt; 5% v/v. Values based on clinicians' or Investigators' recorded values (TGT).</description>
        <time_frame>Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)</time_frame>
        <population>Subjects randomized to the ET control arm of the study who underwent surgery</population>
        <group_list>
          <group group_id="O1">
            <title>ET Control - Desflurane</title>
            <description>Subjects randomized to the ET Control arm of the trial who received Desflurane as their inhaled anesthetic agent.</description>
          </group>
          <group group_id="O2">
            <title>Et Control - Isoflurane</title>
            <description>Subjects randomized to the ET Control arm of the trial who received Isoflurane as their inhaled anesthetic agent.</description>
          </group>
          <group group_id="O3">
            <title>ET Control - Sevoflurane</title>
            <description>Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.</description>
          </group>
          <group group_id="O4">
            <title>ET Control - All</title>
            <description>Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.</description>
          </group>
        </group_list>
        <measure>
          <title>Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)</title>
          <description>Accuracy of Et Control in maintaining EtO2 control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. outcome measures the absolute difference between Steady State and Set EtO2 Concentrations. The acceptable limit defined by the primary endpoint was &lt; 5% v/v. Values based on clinicians' or Investigators' recorded values (TGT).</description>
          <population>Subjects randomized to the ET control arm of the study who underwent surgery</population>
          <units>Absolute Difference (%)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>steady states</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="100"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>steady states</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="147"/>
                <count group_id="O4" value="240"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.62" spread="0.632"/>
                    <measurement group_id="O2" value="0.61" spread="0.585"/>
                    <measurement group_id="O3" value="0.64" spread="0.863"/>
                    <measurement group_id="O4" value="0.63" spread="0.774"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Inhaled Anesthetic Agent</title>
        <description>Usage of inhaled anesthetic agent</description>
        <time_frame>Duration of Procedure</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>User Interactions</title>
        <description>Number of user interactions</description>
        <time_frame>Duration of Procedure</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Discharge From the Operating Room</title>
        <description>Time to discharge from the operating room</description>
        <time_frame>End of surgery to time of last breath</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours</time_frame>
      <desc>For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.</desc>
      <group_list>
        <group group_id="E1">
          <title>Et Control</title>
          <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.&#xD;
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.</description>
        </group>
        <group group_id="E2">
          <title>Control Arm</title>
          <description>Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.&#xD;
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an &quot;end case&quot; is confirmed on the Aisys CS2 at the end of the anesthesia case.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision Loss</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile Leak</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>HR &lt;45bpm more than 5 min</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>HR &gt;110bpm more than 5 min</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="104"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Corneal Abrasion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="104"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Abdominal Cramps</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Throat Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Left Thigh Weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Bladder Spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Bladder Wall Damage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Low Urine Output</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Large Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>SpO2 &lt; 90% for more than 5 min</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Hypercapnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Post-Operative Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Inadvertent Cystotomy and Repair</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Post Operative Pain of 10</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Intraoperative Bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Intractable Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Pain 7 out of 10</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Elevated Heart Rate and Breathing</sub_title>
                <description>Trouble breathing and inadequate reversal of neuromuscular blocking agent led to elevated heart rate and elevated blood pressure which was resolved by sugammadex</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Pain 8 of 10</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Emergence Delay</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Oral Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Pain 9 of 10</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Intermittent Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Dizziness, photophobia, and delay in discharge from PACU</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Severe Post Operative Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension (general)</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="104"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>NIBP SBP&gt;160 mmHg for &gt;5 min</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="104"/>
                <counts group_id="E2" events="24" subjects_affected="24" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>NIBP MAP &gt;120 mmHg for &gt; 5 min</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="104"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>NIPB MAP &lt;55 mmHg for &gt;5 min</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="104"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>NIBP SBP &lt;70 mmHg for &gt;5 min</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Research Program Integrator</name_or_title>
      <organization>GE Healthcare</organization>
      <phone>262-290-6037</phone>
      <email>meghan.terry@ge.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02972892
org study id: 123.07-2015-GES-0002
nct id: NCT02972892
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This is a clinical, single blind, randomized, prospective research study. The purpose of this
      pivotal study is to collect and analyze data on the investigational End tidal Control (Et
      Control) option feature. To demonstrate that End tidal Control (Et Control) performance is
      non-inferior to conventional anesthesia practice in an adult surgery population by comparing
      the performance of the Et Control Arm (investigational arm) to the Control Arm (fresh gas
      mode).
The purpose of this pivotal study is to demonstrate that End tidal Control performance is
      non-inferior to conventional anesthesia practice in an adult surgery population, and support
      a marketing application in the U.S. for clearance of this feature.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Percent Duration Without Large Deviation of End-Tidal Anesthetic Agent (EtAA) Based on Extraction Algorithm (ALG)
time frame: Duration of each steady state, an average of approximately 60 minutes
description: Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Steady state concentration is based on an extraction algorithm described in Appendix 2 of the protocol.
measure: Percent Duration Without Large Deviation of EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
time frame: Duration of each steady state, an average of approximately 60 minutes
description: Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Data obtained using the clinicians' or Investigators' recorded target (TGT) values of anesthetic agent and oxygen for the Control Arm and using the set target values for the Et Control Arm.
measure: Percent Duration Without Large Deviation of End-Tidal Oxygen (EtO2) Based on Extraction Algorithm (ALG)
time frame: Duration of each steady state, an average of approximately 60 minutes
description: Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
measure: Percent Duration Without Large Deviation of EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
time frame: Duration of each steady state, an average of approximately 60 minutes
description: Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Values based on clinicians' or Investigators' recorded target values (TGT)
measure: Efficacy Response Time EtAA Based on Extraction Algorithm (ALG)
time frame: Duration of each steady state, an average of approximately 60 minutes
description: Response time: time to reach 90% of the desired change in EtAA steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
measure: Efficacy: Response Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
time frame: Duration of each steady state, an average of approximately 60 minutes
description: time to reach 90% of the desired change in EtAA and EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).
measure: Efficacy Response Time for EtO2 Based on Extraction Algorithm (ALG)
time frame: Duration of each steady state, an average of approximately 60 minutes.
description: Response time: time to reach 90% of the desired change in EtO2 steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
measure: Efficacy: Response Time for EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
time frame: Duration of each steady state, an average of approximately 60 minutes
description: Response time: time to reach 90% of the desired change in EtAA and EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).
measure: Efficacy: Settling Time for EtAA Based on the Extraction Algorithm (ALG)
time frame: Duration of each steady state, an average of approximately 60 minutes
description: Settling time: time to achieve the desired EtAA steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
measure: Efficacy: Settling Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
time frame: Duration of each steady state, an average of approximately 60 minutes
description: Settling time: time to achieve the desired EtAA steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).
measure: Efficacy: Settling Time for EtO2 Based on the Extraction Algorithm (ALG)
time frame: Duration of each steady state, an average of approximately 60 minutes
description: Settling time: time to achieve the desired EtO2 steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
measure: Efficacy: Settling Time for EtO2 Based on Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
time frame: Duration of each steady state, an average of approximately 60 minutes
description: time to achieve the desired EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).
measure: Efficacy: Overshoot Amount of the Desired EtAA Based on Extraction Algorithm (ALG)
time frame: Duration of each steady state, an average of approximately 60 minutes
description: Overshoot amount of the desired EtAA from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
measure: Efficacy: Overshoot Amount of the Desired EtAA Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
time frame: Duration of each steady state, an average of approximately 60 minutes
description: Overshoot amount of the desired EtAA from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on clinicians' or Investigators' recorded values (TGT).
measure: Efficacy: Overshoot Amount of Desired EtO2 Amount Based on the Extraction Algorithm (ALG)
time frame: Duration of each steady state, an average of approximately 60 minutes
description: Overshoot amount of the desired EtO2 from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
measure: Efficacy: Overshoot Amount of Desired EtO2 Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
time frame: Duration of each steady state, an average of approximately 60 minutes
description: Overshoot amount of the desired EtO2 from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on clinicians' or Investigators' recorded values (TGT).
measure: Accuracy of Et Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG)
time frame: Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)
description: Accuracy of Et Control in maintaining EtAA control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. The accuracy measures include absolute difference between steady state and set EtAA concentrations. The acceptable limits defined by the primary endpoint were: 0.1% of Isoflurane, 0.2% for Sevoflurane, 0.6% for Desflurane. As a measure of Absolute Difference between Steady State and Set EtAA Concentration (%). Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
measure: Accuracy of ET Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
time frame: Duration of Surgery
description: Accuracy of ET Control in maintatining EtAA between user set target and settling end tidal concentrations. Calculated for ET Control arm only. The accuracy measures include absolute difference between steady state and set EtAA concentrations. The acceptable limits defined by the primary endpoint were: 0.1% of Isoflurane, 0.2% for Sevoflurane, 0.6% for Desflurane. Values based on clinicians' or Investigators' recorded values (TGT).
measure: Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG)
time frame: Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)
description: Accuracy of Et Control in maintaining EtO2 control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. outcome measures the absolute difference between Steady State and Set EtO2 Concentrations. The acceptable limit defined by the primary endpoint was < 5% v/v. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
measure: Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
time frame: Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)
description: Accuracy of Et Control in maintaining EtO2 control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. outcome measures the absolute difference between Steady State and Set EtO2 Concentrations. The acceptable limit defined by the primary endpoint was < 5% v/v. Values based on clinicians' or Investigators' recorded values (TGT).
measure: Inhaled Anesthetic Agent
time frame: Duration of Procedure
description: Usage of inhaled anesthetic agent
measure: User Interactions
time frame: Duration of Procedure
description: Number of user interactions
measure: Discharge From the Operating Room
time frame: End of surgery to time of last breath
description: Time to discharge from the operating room
arm group label: Et Control
arm group type: Experimental
description: Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.
arm group label: Control Arm
arm group type: Active Comparator
description: Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.
intervention type: Device
intervention name: Et Control Feature
description: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.
arm group label: Et Control
intervention type: Device
intervention name: Conventional Fresh Gas
description: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.
arm group label: Control Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Melinda Seering, MD
role: Principal Investigator
affiliation: University of Iowa Healthcare
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Data to be shared and reviewed are: adverse events listing, serious adverse event (SAE)/unanticipated adverse device effects (UADE) summary, demographics, surgical procedure, treatment allocation, early termination, critical protocol deviations, device malfunction reports, and plotted data (Et Control subjects with adverse events only). These items are listed in the Data Safety Monitoring Board (DSMB) Charter.
ipd info type: Study Protocol
ipd time frame: Data will be available according to the following timeline: (1) when a minimum of 20 Et Control subjects enrolled and at least 2 sites initiated and enrolling; (2) 50% enrollment; (3) 80% enrollment; and (4) 100% enrollment.
ipd access criteria: Members of the DSMB will have access to the data listed under the Plan Description section. Reports will consist of tables, listings, and figures; and will be delivered electronically at least 7 calendar days prior to the date of each DSMB meeting.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 