<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/NCT03783780</url>
  </required_header>
  <id_info>
    <org_study_id>TP-19564</org_study_id>
    <nct_id>NCT03783780</nct_id>
  </id_info>
  <brief_title>Desaturation Validation of INVSENSOR00031</brief_title>
  <official_title>Desaturation Validation of INVSENSOR00031</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Masimo Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Masimo Corporation</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to compare the accuracy of a noninvasive measurement of oxygen&#xD;
      saturation compared to reference values obtained by a laboratory blood gas analyzer. Arterial&#xD;
      blood samples will be collected from healthy adult subjects while undergoing a desaturation&#xD;
      procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's&#xD;
      arterial oxygen concentration is approximately 70%. During the desaturation, the subject's&#xD;
      hand and arm without the arterial line will be subjected to motion at various times during&#xD;
      the study. The subject will then be returned to breathing room air.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2018</start_date>
  <completion_date type="Actual">December 18, 2018</completion_date>
  <primary_completion_date type="Actual">December 18, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Non-motion</measure>
    <time_frame>1-5 hours</time_frame>
    <description>Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value during non-motion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Motion</measure>
    <time_frame>1-5 hours</time_frame>
    <description>Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value during motion.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>INVSENSOR00031</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>INVSENSOR00031</intervention_name>
    <description>Noninvasive pulse oximeter sensor</description>
    <arm_group_label>INVSENSOR00031</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is 18-50 years of age.&#xD;
&#xD;
          -  Subject weighs a minimum of 110 lbs and no more than 250 lbs unless subject is over 6&#xD;
             feet tall.&#xD;
&#xD;
          -  Hemoglobin value is greater than or equal to 11 g/dL.&#xD;
&#xD;
          -  Baseline heart rate ≥ 45 bpm and ≤ 85 bpm.&#xD;
&#xD;
          -  Carbon monoxide (CO) value ≤ 2.0% fractional carboxyhemoglobin (FCOHb)&#xD;
&#xD;
          -  Subject has a physical status of ASA I or II (American Society of Anesthesiology Class&#xD;
             I; Healthy subjects without any systemic disease at all. American Society of&#xD;
             Anesthesiology Class II; subjects with mild systemic disease) as it applies to the&#xD;
             systemic disease portion of the classification.&#xD;
&#xD;
          -  Systolic Blood Pressure ≤ 140 mmHg and Diastolic Blood Pressure ≤ 90 mmHg.&#xD;
&#xD;
          -  Subject is able to read and communicate in English and understands the study and risks&#xD;
             involved.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is pregnant.&#xD;
&#xD;
          -  Subject smokes (smoking includes e-cigarette use).&#xD;
&#xD;
          -  Subject has a BMI &gt; 35 and has been classified as morbidly obese or at an increased&#xD;
             risk for participation by a medical professional.&#xD;
&#xD;
          -  Subject has a history of fainting (vasovagal), blacking out or losing consciousness&#xD;
             during or after blood draw, or has a fear of blood draws.&#xD;
&#xD;
          -  Subject has open wounds, inflamed tattoos or piercings, or any visible healing wounds&#xD;
             that a medical professional renders them at an increased risk for participation.*&#xD;
&#xD;
          -  Subject experiences frequent or severe headaches and/or migraine headaches.&#xD;
&#xD;
          -  Subject has known drug or alcohol abuse and/or use of recreational drugs.&#xD;
&#xD;
          -  Subject has experienced a concussion or head injury with loss of consciousness within&#xD;
             the last 12 months.&#xD;
&#xD;
          -  Subject has any chronic bleeding disorders (i.e. hemophilia).&#xD;
&#xD;
          -  Subject has any history of a stroke, myocardial infarction, seizures or heart attack.&#xD;
&#xD;
          -  Subject has any cancer or history of cancer (not including skin cancer).*&#xD;
&#xD;
          -  Subject has any cardiac dysrhythmia(s) (i.e. atrial fibrillation) and has not received&#xD;
             clearance by their physician to participate.&#xD;
&#xD;
          -  Subject has a known neurological and/or psychiatric disorder (i.e. schizophrenia,&#xD;
             bipolar disorder, Multiple Sclerosis, Huntington's Disease) that interferes with the&#xD;
             subject's level of consciousness.&#xD;
&#xD;
          -  Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome.&#xD;
&#xD;
          -  Subject who has taken anticoagulant medication within the last 30 days (excluding&#xD;
             nonsteroidal anti-inflammatory drugs (NSAIDS)).&#xD;
&#xD;
          -  Subject has taken opioid pain medication 24 hours before the study.&#xD;
&#xD;
          -  Subject has any type of infectious disease (i.e. Hepatitis, HIV, Tuberculosis, Flu,&#xD;
             Malaria, Measles, etc.)&#xD;
&#xD;
          -  Subject is taking medications known to treat any type of infectious disease.&#xD;
&#xD;
          -  Subject has either signs or history of peripheral ischemia.&#xD;
&#xD;
          -  Subject has had invasive surgery within the past year- including but not limited to&#xD;
             major dental surgery*, appendix*, plastic surgery*.&#xD;
&#xD;
          -  Subject has had invasive surgery within the past year- including but not limited to&#xD;
             gallbladder, heart, major fracture repairs (involving plates/ screws), jaw surgery,&#xD;
             urinary tract surgery, major ears, nose and throat (ENT) surgery, joint replacement or&#xD;
             gynecological surgeries, heart surgery or thoracic surgery.&#xD;
&#xD;
          -  Subject has donated blood within the past 4 weeks.&#xD;
&#xD;
          -  Subject has symptoms of congestion, head colds, flu or other illnesses.&#xD;
&#xD;
          -  Subject experiences claustrophobia or has generalized anxiety disorder.&#xD;
&#xD;
          -  Subject has been in severe car accident(s) or a similar type of accident(s) requiring&#xD;
             hospitalization within the last 12 months.&#xD;
&#xD;
          -  Subject has chronic unresolved asthma, lung disease or respiratory disease.&#xD;
&#xD;
          -  Subject is allergic to lidocaine, latex, adhesives, or plastic.&#xD;
&#xD;
          -  Subject has heart conditions, insulin-dependent Diabetes or uncontrolled hypertension.&#xD;
&#xD;
          -  Subject has given vaginal delivery, had a pregnancy terminated, a miscarriage with&#xD;
             hospitalization, or had a C-section within the last 6 months.&#xD;
&#xD;
          -  Subject intends to participate in any heavy lifting, repetitive movement of their&#xD;
             wrist (including riding a motorcycle) or exercise (working out, riding a bike, riding&#xD;
             a skate board etc.), or any activity that will put additional stress on the wrist&#xD;
             within 24 hours of the study.&#xD;
&#xD;
          -  Subject has any medical condition which in the judgment of the investigator and/or&#xD;
             medical staff, renders them ineligible for participation in this study or subject is&#xD;
             deemed ineligible by the discretion of the investigator/study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Masimo Corporation</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <results_first_submitted>June 12, 2019</results_first_submitted>
  <results_first_submitted_qc>June 12, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 2, 2019</results_first_posted>
  <last_update_submitted>November 26, 2019</last_update_submitted>
  <last_update_submitted_qc>November 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>December 4, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03783780/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>INVSENSOR00031</title>
          <description>All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawn prior to completion</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>INVSENSOR00031</title>
          <description>All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>One subject was withdrawn prior to completing study procedures.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>One subject was withdrawn prior to completing study procedures.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <population>One subject was withdrawn prior to completion of study procedures.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian or Pacific Islander</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Non-motion</title>
        <description>Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value during non-motion.</description>
        <time_frame>1-5 hours</time_frame>
        <population>Only ten subjects, out of the 20 who participated in the study, underwent testing for this non-motion outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>INVSENSOR00031</title>
            <description>All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor.</description>
          </group>
        </group_list>
        <measure>
          <title>Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Non-motion</title>
          <description>Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value during non-motion.</description>
          <population>Only ten subjects, out of the 20 who participated in the study, underwent testing for this non-motion outcome measure.</population>
          <units>% of oxygen saturated hemoglobin</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Motion</title>
        <description>Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value during motion.</description>
        <time_frame>1-5 hours</time_frame>
        <population>Ten subjects were excluded from data analysis from this outcome measure due to insufficient training of the study staff on the motion testing procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>INVSENSOR00031</title>
            <description>All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor.&#xD;
INVSENSOR00031: Noninvasive pulse oximeter sensor</description>
          </group>
        </group_list>
        <measure>
          <title>Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Motion</title>
          <description>Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value during motion.</description>
          <population>Ten subjects were excluded from data analysis from this outcome measure due to insufficient training of the study staff on the motion testing procedure.</population>
          <units>% of oxygen saturated hemoglobin</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 week</time_frame>
      <group_list>
        <group group_id="E1">
          <title>INVSENSOR00031</title>
          <description>All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion.</description>
        </group>
      </group_list>
      <serious_events>
        <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="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Scraped skin</sub_title>
                <description>Subjects skin was scraped with scissors, no visual abrasion</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Tala Harake</name_or_title>
      <organization>Masimo</organization>
      <phone>1-949-297-7100</phone>
      <email>studies@masimo.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/NCT03783780
org study id: TP-19564
nct id: NCT03783780
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
This study is designed to compare the accuracy of a noninvasive measurement of oxygen
      saturation compared to reference values obtained by a laboratory blood gas analyzer. Arterial
      blood samples will be collected from healthy adult subjects while undergoing a desaturation
      procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's
      arterial oxygen concentration is approximately 70%. During the desaturation, the subject's
      hand and arm without the arterial line will be subjected to motion at various times during
      the study. The subject will then be returned to breathing room air.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Non-motion
time frame: 1-5 hours
description: Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value during non-motion.
measure: Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Motion
time frame: 1-5 hours
description: Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value during motion.
arm group label: INVSENSOR00031
arm group type: Experimental
description: All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion.
intervention type: Device
intervention name: INVSENSOR00031
description: Noninvasive pulse oximeter sensor
arm group label: INVSENSOR00031
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 