<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/NCT03024112</url>
  </required_header>
  <id_info>
    <org_study_id>12-1403</org_study_id>
    <nct_id>NCT03024112</nct_id>
  </id_info>
  <brief_title>Impact of Prophylactic High Flow Nasal Oxygen in Post-Operative Thoracic Surgical Patients</brief_title>
  <official_title>Impact of Prophylactic High Flow Nasal Oxygen in Post-Operative Thoracic Surgical Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Investigators goal was to study the effect of high flow nasal cannula oxygen (HFNC) on&#xD;
      the rate of post-operative pulmonary complications in thoracic surgical patients. The&#xD;
      Investigators hypothesis is that prophylactic HFNC oxygen, as compared to standard oxygen&#xD;
      treatment, will reduce the incidence of postoperative pulmonary complications, improve&#xD;
      post-operative pulmonary function, and reduce Intensive Care Unit (ICU) and hospital length&#xD;
      of stay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Investigators goal was to study the effect of high flow nasal cannula oxygen (HFNC) on&#xD;
      the rate of post-operative pulmonary complications in thoracic surgical patients. The&#xD;
      Investigators hypothesis is that prophylactic HFNC oxygen, as compared to standard oxygen&#xD;
      treatment, will reduce the incidence of postoperative pulmonary complications, improve&#xD;
      post-operative pulmonary function, and reduce ICU and hospital length of stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Post-operative Pulmonary Complications</measure>
    <time_frame>30 days</time_frame>
    <description>The primary outcome &quot;post-operative pulmonary complication&quot; is defined as present if any one of the following criteria are met:&#xD;
SpO2 &lt; 90% with FiO2 ≥ 50%&#xD;
Dyspnea at rest&#xD;
Respiratory rate &gt; 25 breaths/min&#xD;
Active use of accessory respiratory muscles&#xD;
PaO2/FiO2 ratio &lt; 200&#xD;
Escalation of therapy to non-invasive ventilation&#xD;
Re-intubation&#xD;
Occurrence of hospital-acquired pneumonia&#xD;
Re-admission to the ICU</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>30 days</time_frame>
    <description>length of stay from hospital admission to hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lowest Oxygen Saturation Level Measured</measure>
    <time_frame>30 days</time_frame>
    <description>Lowest oxygen saturation level measured during hospitalization from admission to discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU Length of Stay</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Post-operative Pulmonary Complications</condition>
  <arm_group>
    <arm_group_label>Heated humidified high-flow nasal cannula (HHFNC) oxygen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender - capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier - providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula - larger diameter, slightly elongated nasal cannula with single limb connection to humidifier</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard oxygen Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Heated humified high-flow nasal cannula Oxygen</intervention_name>
    <arm_group_label>Heated humidified high-flow nasal cannula (HHFNC) oxygen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard oxygen therapy</intervention_name>
    <arm_group_label>Standard oxygen Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing Thoracic surgery&#xD;
&#xD;
          -  Planned admission to ICU after surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Breast feeding&#xD;
&#xD;
          -  Known diagnosis of obstructive sleep apnea&#xD;
&#xD;
          -  Current or previous lung transplant&#xD;
&#xD;
          -  Pneumonectomy&#xD;
&#xD;
          -  Home oxygen greater than 4L/minute&#xD;
&#xD;
          -  Inability to adhere to assigned treatment prior to 48 hours of surgery or until&#xD;
             transferred to a floor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason Brainard, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Unversity of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <results_first_submitted>May 25, 2017</results_first_submitted>
  <results_first_submitted_qc>December 4, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">December 5, 2017</results_first_posted>
  <last_update_submitted>December 4, 2017</last_update_submitted>
  <last_update_submitted_qc>December 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share IPD</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen</title>
          <description>The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender - capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier - providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula - larger diameter, slightly elongated nasal cannula with single limb connection to humidifier&#xD;
Heated humified high-flow nasal cannula Oxygen</description>
        </group>
        <group group_id="P2">
          <title>Standard Oxygen Therapy</title>
          <description>The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.&#xD;
Standard oxygen therapy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen</title>
          <description>The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender - capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier - providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula - larger diameter, slightly elongated nasal cannula with single limb connection to humidifier&#xD;
Heated humified high-flow nasal cannula Oxygen</description>
        </group>
        <group group_id="B2">
          <title>Standard Oxygen Therapy</title>
          <description>The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.&#xD;
Standard oxygen therapy</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="18"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="44"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57" lower_limit="18" upper_limit="100"/>
                    <measurement group_id="B2" value="59" lower_limit="18" upper_limit="100"/>
                    <measurement group_id="B3" value="58" lower_limit="18" upper_limit="100"/>
                  </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="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Post-operative Pulmonary Complications</title>
        <description>The primary outcome &quot;post-operative pulmonary complication&quot; is defined as present if any one of the following criteria are met:&#xD;
SpO2 &lt; 90% with FiO2 ≥ 50%&#xD;
Dyspnea at rest&#xD;
Respiratory rate &gt; 25 breaths/min&#xD;
Active use of accessory respiratory muscles&#xD;
PaO2/FiO2 ratio &lt; 200&#xD;
Escalation of therapy to non-invasive ventilation&#xD;
Re-intubation&#xD;
Occurrence of hospital-acquired pneumonia&#xD;
Re-admission to the ICU</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen</title>
            <description>The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender - capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier - providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula - larger diameter, slightly elongated nasal cannula with single limb connection to humidifier&#xD;
Heated humified high-flow nasal cannula Oxygen</description>
          </group>
          <group group_id="O2">
            <title>Standard Oxygen Therapy</title>
            <description>The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.&#xD;
Standard oxygen therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Post-operative Pulmonary Complications</title>
          <description>The primary outcome &quot;post-operative pulmonary complication&quot; is defined as present if any one of the following criteria are met:&#xD;
SpO2 &lt; 90% with FiO2 ≥ 50%&#xD;
Dyspnea at rest&#xD;
Respiratory rate &gt; 25 breaths/min&#xD;
Active use of accessory respiratory muscles&#xD;
PaO2/FiO2 ratio &lt; 200&#xD;
Escalation of therapy to non-invasive ventilation&#xD;
Re-intubation&#xD;
Occurrence of hospital-acquired pneumonia&#xD;
Re-admission to the ICU</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.680</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Length of Stay</title>
        <description>length of stay from hospital admission to hospital discharge</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen</title>
            <description>The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender - capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier - providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula - larger diameter, slightly elongated nasal cannula with single limb connection to humidifier&#xD;
Heated humified high-flow nasal cannula Oxygen</description>
          </group>
          <group group_id="O2">
            <title>Standard Oxygen Therapy</title>
            <description>The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.&#xD;
Standard oxygen therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Length of Stay</title>
          <description>length of stay from hospital admission to hospital discharge</description>
          <units>Days</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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" spread="2.1"/>
                    <measurement group_id="O2" value="9.5" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lowest Oxygen Saturation Level Measured</title>
        <description>Lowest oxygen saturation level measured during hospitalization from admission to discharge</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen</title>
            <description>The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender - capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier - providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula - larger diameter, slightly elongated nasal cannula with single limb connection to humidifier&#xD;
Heated humified high-flow nasal cannula Oxygen</description>
          </group>
          <group group_id="O2">
            <title>Standard Oxygen Therapy</title>
            <description>The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.&#xD;
Standard oxygen therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Lowest Oxygen Saturation Level Measured</title>
          <description>Lowest oxygen saturation level measured during hospitalization from admission to discharge</description>
          <units>percentage of oxygen saturation</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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88" spread="7"/>
                    <measurement group_id="O2" value="84" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ICU Length of Stay</title>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen</title>
            <description>The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender - capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier - providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula - larger diameter, slightly elongated nasal cannula with single limb connection to humidifier&#xD;
Heated humified high-flow nasal cannula Oxygen</description>
          </group>
          <group group_id="O2">
            <title>Standard Oxygen Therapy</title>
            <description>The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.&#xD;
Standard oxygen therapy</description>
          </group>
        </group_list>
        <measure>
          <title>ICU Length of Stay</title>
          <units>Days</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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" spread="1.2"/>
                    <measurement group_id="O2" value="3.2" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen</title>
          <description>The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender - capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier - providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula - larger diameter, slightly elongated nasal cannula with single limb connection to humidifier&#xD;
Heated humified high-flow nasal cannula Oxygen</description>
        </group>
        <group group_id="E2">
          <title>Standard Oxygen Therapy</title>
          <description>The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.&#xD;
Standard oxygen therapy</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="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary Complications</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </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. Jason Brainard</name_or_title>
      <organization>University of Colorado, Denver</organization>
      <phone>720-848-3257</phone>
      <email>Jason.Brainard@ucdenver.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/NCT03024112
org study id: 12-1403
nct id: NCT03024112
lead sponsor: 
has dmc: No
The Investigators goal was to study the effect of high flow nasal cannula oxygen (HFNC) on
      the rate of post-operative pulmonary complications in thoracic surgical patients. The
      Investigators hypothesis is that prophylactic HFNC oxygen, as compared to standard oxygen
      treatment, will reduce the incidence of postoperative pulmonary complications, improve
      post-operative pulmonary function, and reduce Intensive Care Unit (ICU) and hospital length
      of stay.
The Investigators goal was to study the effect of high flow nasal cannula oxygen (HFNC) on
      the rate of post-operative pulmonary complications in thoracic surgical patients. The
      Investigators hypothesis is that prophylactic HFNC oxygen, as compared to standard oxygen
      treatment, will reduce the incidence of postoperative pulmonary complications, improve
      post-operative pulmonary function, and reduce ICU and hospital length of stay.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Participants With Post-operative Pulmonary Complications
time frame: 30 days
description: The primary outcome "post-operative pulmonary complication" is defined as present if any one of the following criteria are met:
SpO2 < 90% with FiO2 ≥ 50%
Dyspnea at rest
Respiratory rate > 25 breaths/min
Active use of accessory respiratory muscles
PaO2/FiO2 ratio < 200
Escalation of therapy to non-invasive ventilation
Re-intubation
Occurrence of hospital-acquired pneumonia
Re-admission to the ICU
measure: Hospital Length of Stay
time frame: 30 days
description: length of stay from hospital admission to hospital discharge
measure: Lowest Oxygen Saturation Level Measured
time frame: 30 days
description: Lowest oxygen saturation level measured during hospitalization from admission to discharge
measure: ICU Length of Stay
time frame: 30 days
arm group label: Heated humidified high-flow nasal cannula (HHFNC) oxygen
arm group type: Experimental
description: The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender - capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier - providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula - larger diameter, slightly elongated nasal cannula with single limb connection to humidifier
arm group label: Standard oxygen Therapy
arm group type: Active Comparator
description: The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.
intervention type: Device
intervention name: Heated humified high-flow nasal cannula Oxygen
arm group label: Heated humidified high-flow nasal cannula (HHFNC) oxygen
intervention type: Other
intervention name: Standard oxygen therapy
arm group label: Standard oxygen Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jason Brainard, M.D.
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: No plan to share IPD
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 