<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/NCT03235817</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00011814</org_study_id>
    <nct_id>NCT03235817</nct_id>
  </id_info>
  <brief_title>A Comparison of Different Ventilation Strategies in Infants Using the PLMA™</brief_title>
  <official_title>A Comparison of Different Ventilation Strategies in Infants Using the Proseal™ Laryngeal Mask Airway</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this research study is to compare difference between breathing by oneself or&#xD;
      with the partial help from an anesthesia machine in infants under general anesthesia.&#xD;
&#xD;
      Hypothesis: Infants undergoing general anesthesia with a PLMA™ will be better ventilated&#xD;
      (improved breathing) with the help of the breathing machine versus breathing on their own.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The laryngeal mask airway (LMA) is a breathing device that sits above the vocal cords and&#xD;
      allows the patient to breathe in and out adequately under general anesthesia (GA). The&#xD;
      ProSeal™ laryngeal mask airway (PLMA™) is a specialized type of LMA with a design that&#xD;
      permits the delivery of higher pressures to help the patient breathe in and out (ventilate)&#xD;
      and also contains a channel to suction the stomach.&#xD;
&#xD;
      Infants under GA may breathe through a PLMA in different ways. Spontaneous ventilation&#xD;
      consists of the infants breathing on their own through a PLMA™. Pressure support ventilation&#xD;
      allows the patient to breathe on their own with additional help from the anesthesia machine.&#xD;
      Pressure control ventilation allows the patient to breathe with the help of an anesthesia&#xD;
      machine.&#xD;
&#xD;
      An infant undergoing surgery requires a deep level of general anesthesia which negatively&#xD;
      affects their ability to ventilate. Thus, infants may not breathe in oxygen and carbon&#xD;
      dioxide out adequately at this level of anesthesia and it may be beneficial to provide some&#xD;
      level of support to enhance carbon dioxide exchange and to avoid hypoventilation.&#xD;
&#xD;
      This study will attempt to determine whether pressure support ventilation improves&#xD;
      ventilation in infants undergoing outpatient surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2009</start_date>
  <completion_date type="Actual">July 2010</completion_date>
  <primary_completion_date type="Actual">July 2010</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.</measure>
    <time_frame>Up to 45 minutes</time_frame>
    <description>Mean values of end-tidal carbon dioxide (ETCO2) and tidal volume (TV) between 5 and 45 minutes compared between the spontaneous ventilation (SV) and pressure support ventilation groups (PSV).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups</measure>
    <time_frame>Up to 45 minutes</time_frame>
    <description>Mean values of ETCO2 and TV between 5 and 45 minutes compared between the SV and Pressure control ventilation (PCV) groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups</measure>
    <time_frame>up to 45 minutes</time_frame>
    <description>Mean values of ETCO2 and TV between 5 and 45 minutes compared between the PSV and PCV groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Values of Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.</measure>
    <time_frame>Up to 45 minutes</time_frame>
    <description>Mean values of respiratory rate between 5 and 45 minutes compared between spontaneous ventilation and pressure support ventilation groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.</measure>
    <time_frame>Up to 45 minutes</time_frame>
    <description>Mean values of respiratory rate between 5 and 45 minutes compared between the spontaneous ventilation and pressure control ventilation groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.</measure>
    <time_frame>Up to 45 minutes</time_frame>
    <description>Mean values of respiratory rate between 5 and 45 minutes compared between pressure support ventilation and pressure control ventilation groups.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Ventilation</condition>
  <arm_group>
    <arm_group_label>Spontaneous ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Pressure support ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Pressure control ventilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Spontaneous ventilation</intervention_name>
    <description>The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.</description>
    <arm_group_label>Spontaneous ventilation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pressure support ventilation</intervention_name>
    <description>The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.</description>
    <arm_group_label>Pressure support ventilation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pressure control ventilation</intervention_name>
    <description>The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.</description>
    <arm_group_label>Pressure control ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ASA (American Society of Anesthesiologists) physical classification of 1 or 2&#xD;
&#xD;
          2. Outpatient surgical procedures&#xD;
&#xD;
          3. Surgical procedure anticipated to be &lt; 90 minutes&#xD;
&#xD;
          4. Subject age of 1 - 11 months (inclusive)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inpatient- Such individuals may have underlying disease processes which puts them at&#xD;
             an increased risk under general anesthesia for hypoventilation&#xD;
&#xD;
          2. ASA physical classification of 3, 4 or E&#xD;
&#xD;
          3. Premature infants or infants &lt; 44 weeks post-conceptual age&#xD;
&#xD;
          4. Risk of aspiration- Intubation with an endotracheal tube may be required for general&#xD;
             anesthesia.&#xD;
&#xD;
          5. Patients with malignant hyperthermia or family history of malignant hyperthermia-&#xD;
             Administration of inhalational agents for general anesthesia is contraindicated.&#xD;
&#xD;
          6. Patients with tracheostomies- The individual's airway is already established and PLMA™&#xD;
             placement is not required.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>11 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Templeton, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest Baptist Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Brain AI, McGhee TD, McAteer EJ, Thomas A, Abu-Saad MA, Bushman JA. The laryngeal mask airway. Development and preliminary trials of a new type of airway. Anaesthesia. 1985 Apr;40(4):356-61.</citation>
    <PMID>4003736</PMID>
  </reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>February 8, 2013</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <results_first_submitted>November 9, 2017</results_first_submitted>
  <results_first_submitted_qc>December 13, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">January 16, 2018</results_first_posted>
  <last_update_submitted>March 9, 2022</last_update_submitted>
  <last_update_submitted_qc>March 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Proseal™ LMA</keyword>
  <keyword>infants</keyword>
  <keyword>ventilation</keyword>
  <keyword>general anesthesia</keyword>
  <keyword>outpatient surgery</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Spontaneous Ventilation</title>
          <description>Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.</description>
        </group>
        <group group_id="P2">
          <title>Pressure Support Ventilation</title>
          <description>Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.</description>
        </group>
        <group group_id="P3">
          <title>Pressure Control Ventilation</title>
          <description>Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Spontaneous Ventilation</title>
          <description>Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.</description>
        </group>
        <group group_id="B2">
          <title>Pressure Support Ventilation</title>
          <description>Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.</description>
        </group>
        <group group_id="B3">
          <title>Pressure Control Ventilation</title>
          <description>Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.</description>
        </group>
        <group group_id="B4">
          <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="10"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="11"/>
            <count group_id="B4" value="33"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Age</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.1" spread="2"/>
                    <measurement group_id="B2" value="7.3" spread="2"/>
                    <measurement group_id="B3" value="6.9" spread="1.9"/>
                    <measurement group_id="B4" value="7.1" spread="2"/>
                  </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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8" spread="1.7"/>
                    <measurement group_id="B2" value="8.5" spread=".9"/>
                    <measurement group_id="B3" value="8.2" spread="1.3"/>
                    <measurement group_id="B4" value="8.2" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PLMA Size (ProSeal laryngeal mask airway)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Size 1.5</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Size 2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Induction Time</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.5" spread="5.9"/>
                    <measurement group_id="B2" value="8.6" spread="3.3"/>
                    <measurement group_id="B3" value="9.6" spread="3.1"/>
                    <measurement group_id="B4" value="9.2" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.</title>
        <description>Mean values of end-tidal carbon dioxide (ETCO2) and tidal volume (TV) between 5 and 45 minutes compared between the spontaneous ventilation (SV) and pressure support ventilation groups (PSV).</description>
        <time_frame>Up to 45 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Spontaneous Ventilation</title>
            <description>Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.</description>
          </group>
          <group group_id="O2">
            <title>Pressure Support Ventilation</title>
            <description>Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.</title>
          <description>Mean values of end-tidal carbon dioxide (ETCO2) and tidal volume (TV) between 5 and 45 minutes compared between the spontaneous ventilation (SV) and pressure support ventilation groups (PSV).</description>
          <units>cc/kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mean Values of Tidal Volume</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread=".3"/>
                    <measurement group_id="O2" value="7" spread=".5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean Values of End-Tidal Carbon Dioxide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.8" spread="2.9"/>
                    <measurement group_id="O2" value="49" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups</title>
        <description>Mean values of ETCO2 and TV between 5 and 45 minutes compared between the SV and Pressure control ventilation (PCV) groups.</description>
        <time_frame>Up to 45 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Spontaneous Ventilation</title>
            <description>Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.</description>
          </group>
          <group group_id="O2">
            <title>Pressure Control Ventilation</title>
            <description>Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups</title>
          <description>Mean values of ETCO2 and TV between 5 and 45 minutes compared between the SV and Pressure control ventilation (PCV) groups.</description>
          <units>cc/kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ETCO2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.8" spread="2.9"/>
                    <measurement group_id="O2" value="48.3" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="0.3"/>
                    <measurement group_id="O2" value="7.0" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups</title>
        <description>Mean values of ETCO2 and TV between 5 and 45 minutes compared between the PSV and PCV groups</description>
        <time_frame>up to 45 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pressure Support Ventilation</title>
            <description>Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.</description>
          </group>
          <group group_id="O2">
            <title>Pressure Control Ventilation</title>
            <description>Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups</title>
          <description>Mean values of ETCO2 and TV between 5 and 45 minutes compared between the PSV and PCV groups</description>
          <units>cc/kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ETCO2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.0" spread="1.5"/>
                    <measurement group_id="O2" value="48.3" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" spread="0.5"/>
                    <measurement group_id="O2" value="7.0" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Values of Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.</title>
        <description>Mean values of respiratory rate between 5 and 45 minutes compared between spontaneous ventilation and pressure support ventilation groups.</description>
        <time_frame>Up to 45 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Spontaneous Ventilation</title>
            <description>Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.</description>
          </group>
          <group group_id="O2">
            <title>Pressure Support Ventilation</title>
            <description>Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Values of Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.</title>
          <description>Mean values of respiratory rate between 5 and 45 minutes compared between spontaneous ventilation and pressure support ventilation groups.</description>
          <units>breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.2" spread="2.2"/>
                    <measurement group_id="O2" value="25.1" spread=".8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.</title>
        <description>Mean values of respiratory rate between 5 and 45 minutes compared between the spontaneous ventilation and pressure control ventilation groups.</description>
        <time_frame>Up to 45 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Spontaneous Ventilation</title>
            <description>Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.</description>
          </group>
          <group group_id="O2">
            <title>Pressure Control Ventilation</title>
            <description>Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.</title>
          <description>Mean values of respiratory rate between 5 and 45 minutes compared between the spontaneous ventilation and pressure control ventilation groups.</description>
          <units>breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.2" spread="2.2"/>
                    <measurement group_id="O2" value="22.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.</title>
        <description>Mean values of respiratory rate between 5 and 45 minutes compared between pressure support ventilation and pressure control ventilation groups.</description>
        <time_frame>Up to 45 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pressure Support Ventilation</title>
            <description>Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.</description>
          </group>
          <group group_id="O2">
            <title>Pressure Control Ventilation</title>
            <description>Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.</title>
          <description>Mean values of respiratory rate between 5 and 45 minutes compared between pressure support ventilation and pressure control ventilation groups.</description>
          <units>breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.1" spread=".8"/>
                    <measurement group_id="O2" value="22.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Spontaneous Ventilation</title>
          <description>Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.</description>
        </group>
        <group group_id="E2">
          <title>Pressure Support Ventilation</title>
          <description>Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.</description>
        </group>
        <group group_id="E3">
          <title>Pressure Control Ventilation</title>
          <description>Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.</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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </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>T. Wesley Templeton, MD</name_or_title>
      <organization>Anesthesiology</organization>
      <phone>336-716-4498</phone>
      <email>ttemplet@wakehealth.edu</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/NCT03235817
org study id: IRB00011814
nct id: NCT03235817
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this research study is to compare difference between breathing by oneself or
      with the partial help from an anesthesia machine in infants under general anesthesia.

      Hypothesis: Infants undergoing general anesthesia with a PLMA™ will be better ventilated
      (improved breathing) with the help of the breathing machine versus breathing on their own.
The laryngeal mask airway (LMA) is a breathing device that sits above the vocal cords and
      allows the patient to breathe in and out adequately under general anesthesia (GA). The
      ProSeal™ laryngeal mask airway (PLMA™) is a specialized type of LMA with a design that
      permits the delivery of higher pressures to help the patient breathe in and out (ventilate)
      and also contains a channel to suction the stomach.

      Infants under GA may breathe through a PLMA in different ways. Spontaneous ventilation
      consists of the infants breathing on their own through a PLMA™. Pressure support ventilation
      allows the patient to breathe on their own with additional help from the anesthesia machine.
      Pressure control ventilation allows the patient to breathe with the help of an anesthesia
      machine.

      An infant undergoing surgery requires a deep level of general anesthesia which negatively
      affects their ability to ventilate. Thus, infants may not breathe in oxygen and carbon
      dioxide out adequately at this level of anesthesia and it may be beneficial to provide some
      level of support to enhance carbon dioxide exchange and to avoid hypoventilation.

      This study will attempt to determine whether pressure support ventilation improves
      ventilation in infants undergoing outpatient surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.
time frame: Up to 45 minutes
description: Mean values of end-tidal carbon dioxide (ETCO2) and tidal volume (TV) between 5 and 45 minutes compared between the spontaneous ventilation (SV) and pressure support ventilation groups (PSV).
measure: Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups
time frame: Up to 45 minutes
description: Mean values of ETCO2 and TV between 5 and 45 minutes compared between the SV and Pressure control ventilation (PCV) groups.
measure: Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups
time frame: up to 45 minutes
description: Mean values of ETCO2 and TV between 5 and 45 minutes compared between the PSV and PCV groups
measure: Mean Values of Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.
time frame: Up to 45 minutes
description: Mean values of respiratory rate between 5 and 45 minutes compared between spontaneous ventilation and pressure support ventilation groups.
measure: Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.
time frame: Up to 45 minutes
description: Mean values of respiratory rate between 5 and 45 minutes compared between the spontaneous ventilation and pressure control ventilation groups.
measure: Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.
time frame: Up to 45 minutes
description: Mean values of respiratory rate between 5 and 45 minutes compared between pressure support ventilation and pressure control ventilation groups.
arm group label: Spontaneous ventilation
arm group type: Experimental
arm group label: Pressure support ventilation
arm group type: Experimental
arm group label: Pressure control ventilation
arm group type: Active Comparator
intervention type: Other
intervention name: Spontaneous ventilation
description: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
arm group label: Spontaneous ventilation
intervention type: Device
intervention name: Pressure support ventilation
description: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
arm group label: Pressure support ventilation
intervention type: Device
intervention name: Pressure control ventilation
description: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
arm group label: Pressure control ventilation
criteria: 
gender: All
minimum age: 1 Month
maximum age: 11 Months
healthy volunteers: No
last name: Thomas Templeton, M.D.
role: Principal Investigator
affiliation: Wake Forest
facility: 
country: United States
citation: Brain AI, McGhee TD, McAteer EJ, Thomas A, Abu-Saad MA, Bushman JA. The laryngeal mask airway. Development and preliminary trials of a new type of airway. Anaesthesia. 1985 Apr;40(4):356-61.
PMID: 4003736
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 