<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/NCT03766646</url>
  </required_header>
  <id_info>
    <org_study_id>RHM CR10369</org_study_id>
    <nct_id>NCT03766646</nct_id>
  </id_info>
  <brief_title>Preoxygenation With Optiflow™ - the Effect of Speech on Lung Oxygenation.</brief_title>
  <official_title>Preoxygenation With High Flow Nasal Oxygenation Using Optiflow - Does Speech Have an Effect on The End Tidal Oxygen Achieved When Compared to Closed Mouth Nasal Breathing?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Southampton NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Southampton NHS Foundation Trust</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>
      If a patient speaks during the process of preoxygenation with high-flow nasal oxygen via the&#xD;
      Optiflow™ system, is the efficacy reduced as measured by end-tidal lung oxygen content?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomised controlled trial on 34 patients undergoing routine elective surgery at&#xD;
      the Princess Anne Hospital, Southampton. The study will take place from September 2018 to&#xD;
      January 2019 and involve preoxygenating all participants for three minutes using the&#xD;
      Optiflow™ device. During this time, participants will be instructed to either read aloud a&#xD;
      standardised text or to breathe through their nose with a closed mouth. At the end of 3&#xD;
      minutes, the primary outcome, ETO2, will be measured and recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 18, 2018</start_date>
  <completion_date type="Actual">November 16, 2018</completion_date>
  <primary_completion_date type="Actual">November 16, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients were assigned to either the 'Speech' arm or 'Non-speech' arm of the study</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>After recruitment, patients were randomised into one of two arms, speech or non-speech. Both the investigator and the participant were aware of the intervention assigned</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>End Tidal Oxygen Fraction</measure>
    <time_frame>At the end of 3 minutes preoxygenation</time_frame>
    <description>Oxygen fraction in first expired breath post preoxygenation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Unrecognized Condition</condition>
  <arm_group>
    <arm_group_label>Speech</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were asked to read a standardised script aloud for 3 minutes whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-speech</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants were asked to breathe in and out of their nose for 3 minutes, with a closed mouth, whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Optiflow</intervention_name>
    <description>45l.min oxygen</description>
    <arm_group_label>Non-speech</arm_group_label>
    <arm_group_label>Speech</arm_group_label>
    <other_name>HFNO, High Flow Nasal Oxygen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI 18-35, ASA category 1 or 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to read/ follow instructions, Heavily sedated&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick Butler</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unvistery Hospital Southampton</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Southampton</name>
      <address>
        <city>Southampton</city>
        <state>Hants</state>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <results_first_submitted>February 19, 2019</results_first_submitted>
  <results_first_submitted_qc>October 26, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 30, 2020</results_first_posted>
  <last_update_submitted>October 26, 2020</last_update_submitted>
  <last_update_submitted_qc>October 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Optiflow</keyword>
  <keyword>High Flow Nasal Oxygen</keyword>
  <keyword>Preoxygenation</keyword>
  <keyword>Speech</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT03766646/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 17, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT03766646/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Speech</title>
          <description>Participants were asked to read a standardised script aloud for 3 minutes whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.&#xD;
Optiflow: 45l.min oxygen</description>
        </group>
        <group group_id="P2">
          <title>Non-speech</title>
          <description>Participants were asked to breathe in and out of their nose for 3 minutes, with a closed mouth, whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.&#xD;
Optiflow: 45l.min oxygen</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Speech</title>
          <description>Participants were asked to read a standardised script aloud for 3 minutes whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.&#xD;
Optiflow: 45l.min oxygen</description>
        </group>
        <group group_id="B2">
          <title>Non-speech</title>
          <description>Participants were asked to breathe in and out of their nose for 3 minutes, with a closed mouth, whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.&#xD;
Optiflow: 45l.min oxygen</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="34"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Participants not suitable for analysis</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="18"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Participant withdrawal/ unsuitable for analysis</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="18"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="30"/>
                  </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_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_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg.m-2</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.0" lower_limit="20.3" upper_limit="31.8"/>
                    <measurement group_id="B2" value="26.5" lower_limit="21.1" upper_limit="35.4"/>
                    <measurement group_id="B3" value="26.7" lower_limit="20.3" upper_limit="35.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>End Tidal Oxygen Fraction</title>
        <description>Oxygen fraction in first expired breath post preoxygenation</description>
        <time_frame>At the end of 3 minutes preoxygenation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Speech</title>
            <description>Participants were asked to read a standardised script aloud for 3 minutes whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.&#xD;
Optiflow: 45l.min oxygen</description>
          </group>
          <group group_id="O2">
            <title>Non-speech</title>
            <description>Participants were asked to breathe in and out of their nose for 3 minutes, with a closed mouth, whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.&#xD;
Optiflow: 45l.min oxygen</description>
          </group>
        </group_list>
        <measure>
          <title>End Tidal Oxygen Fraction</title>
          <description>Oxygen fraction in first expired breath post preoxygenation</description>
          <units>percentage of End-Tidal Oxygen Fraction</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.9" spread="15.4"/>
                    <measurement group_id="O2" value="81.9" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Speech</title>
          <description>Participants were asked to read a standardised script aloud for 3 minutes whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.&#xD;
Optiflow: 45l.min oxygen&#xD;
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not monitored/assessed.</description>
        </group>
        <group group_id="E2">
          <title>Non-speech</title>
          <description>Participants were asked to breathe in and out of their nose for 3 minutes, with a closed mouth, whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.&#xD;
Optiflow: 45l.min oxygen&#xD;
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not monitored/assessed.</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>
    <point_of_contact>
      <name_or_title>Dr Patrick Butler</name_or_title>
      <organization>University Hospital Southampton</organization>
      <phone>81205662 ext +44 (0)23</phone>
      <email>patrick.butler@uhs.nhs.uk</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/NCT03766646
org study id: RHM CR10369
nct id: NCT03766646
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
If a patient speaks during the process of preoxygenation with high-flow nasal oxygen via the
      Optiflow™ system, is the efficacy reduced as measured by end-tidal lung oxygen content?
This is a randomised controlled trial on 34 patients undergoing routine elective surgery at
      the Princess Anne Hospital, Southampton. The study will take place from September 2018 to
      January 2019 and involve preoxygenating all participants for three minutes using the
      Optiflow™ device. During this time, participants will be instructed to either read aloud a
      standardised text or to breathe through their nose with a closed mouth. At the end of 3
      minutes, the primary outcome, ETO2, will be measured and recorded.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients were assigned to either the 'Speech' arm or 'Non-speech' arm of the study
primary purpose: Health Services Research
masking: None (Open Label)
masking description: After recruitment, patients were randomised into one of two arms, speech or non-speech. Both the investigator and the participant were aware of the intervention assigned
measure: End Tidal Oxygen Fraction
time frame: At the end of 3 minutes preoxygenation
description: Oxygen fraction in first expired breath post preoxygenation
arm group label: Speech
arm group type: Experimental
description: Participants were asked to read a standardised script aloud for 3 minutes whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.
arm group label: Non-speech
arm group type: Active Comparator
description: Participants were asked to breathe in and out of their nose for 3 minutes, with a closed mouth, whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.
intervention type: Device
intervention name: Optiflow
description: 45l.min oxygen
arm group label: Non-speech
arm group label: Speech
other name: HFNO, High Flow Nasal Oxygen
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Patrick Butler
role: Principal Investigator
affiliation: Unvistery Hospital Southampton
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 