<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/NCT03772574</url>
  </required_header>
  <id_info>
    <org_study_id>H18-02855</org_study_id>
    <nct_id>NCT03772574</nct_id>
  </id_info>
  <brief_title>Preoxygenation Using THRIVE Versus Facemask in Parturients</brief_title>
  <official_title>Preoxygenation Using THRIVE and Facemask Oxygenation in Parturients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to determine the duration for pre-oxygenation using THRIVE and facemask for&#xD;
      parturients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We aim to determine the duration required for THRIVE and facemask preoxygenation in&#xD;
      parturients for them to achieve ETO2 &gt;90%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">April 24, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 2019</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Preoxygenation Duration</measure>
    <time_frame>Maximum 8 minutes</time_frame>
    <description>Duration to achieve EtO2 &gt;=90% after tidal volume breathing using THRIVE and facemask pre-oxygenation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes</measure>
    <time_frame>3 minutes of pre-oxygenation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion to Reach EtO2 of 90 Percent at 4 Minutes</measure>
    <time_frame>4 minutes of preoxygenation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion to Reach EtO2 of 90 Percent at 5 Minutes</measure>
    <time_frame>5 minutes of preoxygenation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion to Reach EtO2 of 90 Percent at 6 Minutes</measure>
    <time_frame>6 minutes of preoxygenation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion to Reach EtO2 of 90 Percent at 7 Minutes</measure>
    <time_frame>7 minutes of preoxygenation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion to Reach EtO2 of 90 Percent at 8 Minutes</measure>
    <time_frame>8 minutes of preoxygenation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comfort Score</measure>
    <time_frame>1 minute after data collection</time_frame>
    <description>Patients were asked to rate their comfort with the device on a 5 point Likert Scale: (1=completely uncomfortable, 2=slightly uncomfortable, 3=neutral, 4=slightly comfortable, 5= completely comfortable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability Score</measure>
    <time_frame>1 minute after data collection</time_frame>
    <description>Acceptability was measured with a 5-point Likert Score (1= unacceptable, 2=slightly unacceptable,3=neutral, 4=slightly acceptable, 5=acceptable).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Preoxygenation</condition>
  <arm_group>
    <arm_group_label>THRIVE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Facemask</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Facemask preoxygenation</intervention_name>
    <description>Standard facemask preoxygenation</description>
    <arm_group_label>Facemask</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>THRIVE preoxygenation</intervention_name>
    <description>Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
    <arm_group_label>THRIVE</arm_group_label>
    <other_name>THRIVE</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant patients ≥36 weeks gestation.&#xD;
&#xD;
          -  Non-laboring patients admitted for elective Cesarean delivery under neuraxial&#xD;
             anesthesia or induction of labor.&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) class 2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any medical conditions that are likely to affect gas exchange.&#xD;
&#xD;
          -  Obstructed nasal passage.&#xD;
&#xD;
          -  Unable to tolerate a tight fitting facemask.&#xD;
&#xD;
          -  Body Mass Index ≥40 kg/m2.&#xD;
&#xD;
          -  Patients who are in active labor (i.e. cervical dilation ≥4cm).&#xD;
&#xD;
          -  Patients who are unable to give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anton Chau, MD MMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BC Women's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3N1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 8, 2018</study_first_submitted>
  <study_first_submitted_qc>December 8, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <results_first_submitted>September 8, 2020</results_first_submitted>
  <results_first_submitted_qc>May 22, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 24, 2022</results_first_posted>
  <last_update_submitted>May 22, 2022</last_update_submitted>
  <last_update_submitted_qc>May 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Anthony Chau</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>February 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03772574/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>91 patients provided informed consent in order to reach the recruitment goal of 80 patients. This is the reason for the discrepancy mentioned in the comments.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Standard Facemask</title>
          <description>Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).&#xD;
Facemask preoxygenation: Standard facemask preoxygenation</description>
        </group>
        <group group_id="P2">
          <title>THRIVE</title>
          <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
        </group>
        <group group_id="P3">
          <title>THRIVE and Facemask</title>
          <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discomfort</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standard Facemask</title>
          <description>Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).&#xD;
Facemask preoxygenation: Standard facemask preoxygenation</description>
        </group>
        <group group_id="B2">
          <title>THRIVE</title>
          <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
        </group>
        <group group_id="B3">
          <title>THRIVE and Facemask</title>
          <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</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="40"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="20"/>
            <count group_id="B4" value="80"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.5" spread="4.3"/>
                    <measurement group_id="B2" value="35" spread="4.1"/>
                    <measurement group_id="B3" value="35" spread="4.4"/>
                    <measurement group_id="B4" value="35.3" spread="4.2"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</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="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" value="0"/>
                  </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>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gravidity</title>
          <units>Pregnancies</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" lower_limit="2" upper_limit="3"/>
                    <measurement group_id="B2" value="2" lower_limit="2" upper_limit="4"/>
                    <measurement group_id="B3" value="2" lower_limit="2" upper_limit="2"/>
                    <measurement group_id="B4" value="2" lower_limit="2" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parity</title>
          <units>births</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="B2" value="1" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="B3" value="1" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="B4" value="1" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gestational age</title>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.6" spread="1.0"/>
                    <measurement group_id="B2" value="38.7" spread="1.1"/>
                    <measurement group_id="B3" value="39.1" spread="0.6"/>
                    <measurement group_id="B4" value="38.8" spread="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline respiratory rate</title>
          <units>breaths/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.9" spread="3.7"/>
                    <measurement group_id="B2" value="14.5" spread="4.1"/>
                    <measurement group_id="B3" value="13.3" spread="3.1"/>
                    <measurement group_id="B4" value="12.9" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline End Tidal Oxygen (ETO2)</title>
          <units>Percent of oxygen in expired breath</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.7" spread="1.2"/>
                    <measurement group_id="B2" value="15.7" spread="0.9"/>
                    <measurement group_id="B3" value="15.8" spread="1.0"/>
                    <measurement group_id="B4" value="15.7" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Heart Rate</title>
          <units>bpm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.4" spread="10.8"/>
                    <measurement group_id="B2" value="76.1" spread="9.7"/>
                    <measurement group_id="B3" value="75.2" spread="13.9"/>
                    <measurement group_id="B4" value="75.1" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Oxygen Saturation (SPO2)</title>
          <units>percent of hemoglobin carrying oxygen</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="98.0" spread="1.5"/>
                    <measurement group_id="B2" value="98.4" spread="1.4"/>
                    <measurement group_id="B3" value="98.5" spread="1.4"/>
                    <measurement group_id="B4" value="98.2" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.1" spread="3.7"/>
                    <measurement group_id="B2" value="29.5" spread="4.8"/>
                    <measurement group_id="B3" value="30.4" spread="3.8"/>
                    <measurement group_id="B4" value="29.5" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Preoxygenation Duration</title>
        <description>Duration to achieve EtO2 &gt;=90% after tidal volume breathing using THRIVE and facemask pre-oxygenation.</description>
        <time_frame>Maximum 8 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Facemask</title>
            <description>Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).&#xD;
Facemask preoxygenation: Standard facemask preoxygenation</description>
          </group>
          <group group_id="O2">
            <title>THRIVE</title>
            <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
          </group>
          <group group_id="O3">
            <title>THRIVE and Facemask</title>
            <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
          </group>
        </group_list>
        <measure>
          <title>Preoxygenation Duration</title>
          <description>Duration to achieve EtO2 &gt;=90% after tidal volume breathing using THRIVE and facemask pre-oxygenation.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="3.3" upper_limit="6.7"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">A value could not be entered, as the longest possible preoxygenation time allotment (8 minutes) was insufficient to produce an EI90</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">A value could not be entered, as the longest possible preoxygenation time allotment (8 minutes) was insufficient to produce an EI90</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes</title>
        <time_frame>3 minutes of pre-oxygenation</time_frame>
        <population>Patients selected to receive 3 minutes of pre-oxygenation</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Facemask</title>
            <description>Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).&#xD;
Facemask preoxygenation: Standard facemask preoxygenation</description>
          </group>
          <group group_id="O2">
            <title>THRIVE</title>
            <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
          </group>
          <group group_id="O3">
            <title>THRIVE and Facemask</title>
            <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes</title>
          <population>Patients selected to receive 3 minutes of pre-oxygenation</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion to Reach EtO2 of 90 Percent at 4 Minutes</title>
        <time_frame>4 minutes of preoxygenation</time_frame>
        <population>Patients assigned to recieve 4 minutes of pre-oxygenation</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Facemask</title>
            <description>Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).&#xD;
Facemask preoxygenation: Standard facemask preoxygenation</description>
          </group>
          <group group_id="O2">
            <title>THRIVE</title>
            <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
          </group>
          <group group_id="O3">
            <title>THRIVE and Facemask</title>
            <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion to Reach EtO2 of 90 Percent at 4 Minutes</title>
          <population>Patients assigned to recieve 4 minutes of pre-oxygenation</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion to Reach EtO2 of 90 Percent at 5 Minutes</title>
        <time_frame>5 minutes of preoxygenation</time_frame>
        <population>Patients assigned to receive 5 minutes of pre-oxygenation</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Facemask</title>
            <description>Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).&#xD;
Facemask preoxygenation: Standard facemask preoxygenation</description>
          </group>
          <group group_id="O2">
            <title>THRIVE</title>
            <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
          </group>
          <group group_id="O3">
            <title>THRIVE and Facemask</title>
            <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion to Reach EtO2 of 90 Percent at 5 Minutes</title>
          <population>Patients assigned to receive 5 minutes of pre-oxygenation</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion to Reach EtO2 of 90 Percent at 6 Minutes</title>
        <time_frame>6 minutes of preoxygenation</time_frame>
        <population>Patients assigned to receive 6 minutes of preoxygenation</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Facemask</title>
            <description>Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).&#xD;
Facemask preoxygenation: Standard facemask preoxygenation</description>
          </group>
          <group group_id="O2">
            <title>THRIVE</title>
            <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
          </group>
          <group group_id="O3">
            <title>THRIVE and Facemask</title>
            <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion to Reach EtO2 of 90 Percent at 6 Minutes</title>
          <population>Patients assigned to receive 6 minutes of preoxygenation</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion to Reach EtO2 of 90 Percent at 7 Minutes</title>
        <time_frame>7 minutes of preoxygenation</time_frame>
        <population>Patients assigned to receive 7 minutes of preoxygenation</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Facemask</title>
            <description>Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).&#xD;
Facemask preoxygenation: Standard facemask preoxygenation</description>
          </group>
          <group group_id="O2">
            <title>THRIVE</title>
            <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
          </group>
          <group group_id="O3">
            <title>THRIVE and Facemask</title>
            <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion to Reach EtO2 of 90 Percent at 7 Minutes</title>
          <population>Patients assigned to receive 7 minutes of preoxygenation</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion to Reach EtO2 of 90 Percent at 8 Minutes</title>
        <time_frame>8 minutes of preoxygenation</time_frame>
        <population>patients assigned to receive 8 minuets of pre-oxygenation</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Facemask</title>
            <description>Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).&#xD;
Facemask preoxygenation: Standard facemask preoxygenation</description>
          </group>
          <group group_id="O2">
            <title>THRIVE</title>
            <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
          </group>
          <group group_id="O3">
            <title>THRIVE and Facemask</title>
            <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion to Reach EtO2 of 90 Percent at 8 Minutes</title>
          <population>patients assigned to receive 8 minuets of pre-oxygenation</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comfort Score</title>
        <description>Patients were asked to rate their comfort with the device on a 5 point Likert Scale: (1=completely uncomfortable, 2=slightly uncomfortable, 3=neutral, 4=slightly comfortable, 5= completely comfortable)</description>
        <time_frame>1 minute after data collection</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Facemask</title>
            <description>Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).&#xD;
Facemask preoxygenation: Standard facemask preoxygenation</description>
          </group>
          <group group_id="O2">
            <title>THRIVE</title>
            <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
          </group>
          <group group_id="O3">
            <title>THRIVE and Facemask</title>
            <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
          </group>
        </group_list>
        <measure>
          <title>Comfort Score</title>
          <description>Patients were asked to rate their comfort with the device on a 5 point Likert Scale: (1=completely uncomfortable, 2=slightly uncomfortable, 3=neutral, 4=slightly comfortable, 5= completely comfortable)</description>
          <units>Likert Score</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="2" upper_limit="5"/>
                    <measurement group_id="O2" value="4" lower_limit="2" upper_limit="4"/>
                    <measurement group_id="O3" value="4" lower_limit="3" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acceptability Score</title>
        <description>Acceptability was measured with a 5-point Likert Score (1= unacceptable, 2=slightly unacceptable,3=neutral, 4=slightly acceptable, 5=acceptable).</description>
        <time_frame>1 minute after data collection</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Facemask</title>
            <description>Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).&#xD;
Facemask preoxygenation: Standard facemask preoxygenation</description>
          </group>
          <group group_id="O2">
            <title>THRIVE</title>
            <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
          </group>
          <group group_id="O3">
            <title>THRIVE and Facemask</title>
            <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability Score</title>
          <description>Acceptability was measured with a 5-point Likert Score (1= unacceptable, 2=slightly unacceptable,3=neutral, 4=slightly acceptable, 5=acceptable).</description>
          <units>Likert Score</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="4" upper_limit="5"/>
                    <measurement group_id="O2" value="4.5" lower_limit="3.75" upper_limit="5"/>
                    <measurement group_id="O3" value="5" lower_limit="5" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 months</time_frame>
      <desc>Patients are not at risk of any adverse events other than some discomfort during preoxygentaion. The study team was careful to avoid complications of pressure related damage to the lungs, by limiting the period of time patients were exposed to high flow oxygen to 8 minutes.</desc>
      <group_list>
        <group group_id="E1">
          <title>Standard Facemask</title>
          <description>Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).&#xD;
Facemask preoxygenation: Standard facemask preoxygenation</description>
        </group>
        <group group_id="E2">
          <title>THRIVE</title>
          <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</description>
        </group>
        <group group_id="E3">
          <title>THRIVE and Facemask</title>
          <description>THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment&#xD;
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).</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="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
              </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="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
              </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>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>
    <limitations_and_caveats>Our results are specific to healthy parturients using standard facemasks, or a high oxygen flow rate of 50L/min, and cannot be generalized to other techniques or populations. 9 parturients left the study due to discomfort, which may bias outcomes</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Anthony Chau</name_or_title>
      <organization>BC Women's Hospital</organization>
      <phone>604-875-2158</phone>
      <email>anton.chau@ubc.ca</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/NCT03772574
org study id: H18-02855
nct id: NCT03772574
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to determine the duration for pre-oxygenation using THRIVE and facemask for
      parturients.
We aim to determine the duration required for THRIVE and facemask preoxygenation in
      parturients for them to achieve ETO2 >90%.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Preoxygenation Duration
time frame: Maximum 8 minutes
description: Duration to achieve EtO2 >=90% after tidal volume breathing using THRIVE and facemask pre-oxygenation.
measure: Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes
time frame: 3 minutes of pre-oxygenation
measure: Proportion to Reach EtO2 of 90 Percent at 4 Minutes
time frame: 4 minutes of preoxygenation
measure: Proportion to Reach EtO2 of 90 Percent at 5 Minutes
time frame: 5 minutes of preoxygenation
measure: Proportion to Reach EtO2 of 90 Percent at 6 Minutes
time frame: 6 minutes of preoxygenation
measure: Proportion to Reach EtO2 of 90 Percent at 7 Minutes
time frame: 7 minutes of preoxygenation
measure: Proportion to Reach EtO2 of 90 Percent at 8 Minutes
time frame: 8 minutes of preoxygenation
measure: Comfort Score
time frame: 1 minute after data collection
description: Patients were asked to rate their comfort with the device on a 5 point Likert Scale: (1=completely uncomfortable, 2=slightly uncomfortable, 3=neutral, 4=slightly comfortable, 5= completely comfortable)
measure: Acceptability Score
time frame: 1 minute after data collection
description: Acceptability was measured with a 5-point Likert Score (1= unacceptable, 2=slightly unacceptable,3=neutral, 4=slightly acceptable, 5=acceptable).
arm group label: THRIVE
arm group type: Experimental
description: THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).
arm group label: Facemask
arm group type: Active Comparator
description: Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).
intervention type: Device
intervention name: Facemask preoxygenation
description: Standard facemask preoxygenation
arm group label: Facemask
intervention type: Device
intervention name: THRIVE preoxygenation
description: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
arm group label: THRIVE
other name: THRIVE
criteria: 
gender: Female
gender based: Yes
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Anton Chau, MD MMSc
role: Principal Investigator
affiliation: University of British Columbia
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Anthony Chau
investigator title: Clinical Assistant Professor
mesh term: Nicotine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Our results are specific to healthy parturients using standard facemasks, or a high oxygen flow rate of 50L/min, and cannot be generalized to other techniques or populations. 9 parturients left the study due to discomfort, which may bias outcomes
point of contact: 