<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/NCT03246893</url>
  </required_header>
  <id_info>
    <org_study_id>Si212/2017</org_study_id>
    <nct_id>NCT03246893</nct_id>
  </id_info>
  <brief_title>Efficacy of HFNC Versus NIV for Prevent Reintubation in Sepsis Patients</brief_title>
  <official_title>Efficacy of High Flow Oxygen Nasal Cannula Versus Noninvasive Positive Pressure Ventilation After Extubation in Sepsis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</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>
      Post extubation respiratory failure occur in 30% of extubated patients. More than 50% of them&#xD;
      required reintubation. Noninvasive positive pressure ventilation (NIV) had been reported as&#xD;
      an effective tool to prevent post extubation respiratory failure. Recently, high flow oxygen&#xD;
      nasal cannula (HFNC) had been successfully used to prevent post extubation respiratory&#xD;
      failure and prevent reintubation in comparable with NIV among post cardiothoracic surgery and&#xD;
      high risk for reintubated patients. There was no information about HFNC versus NIV in&#xD;
      prevention of reintubation among severe sepsis or septic shock patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Post extubation respiratory failure occur in 30% of extubated patients. More than 50% of them&#xD;
      required reintubation. Noninvasive positive pressure ventilation (NIV) had been reported as&#xD;
      an effective tool to prevent post extubation respiratory failure. Recently, high flow oxygen&#xD;
      nasal cannula (HFNC) had been successfully used to prevent post extubation respiratory&#xD;
      failure and prevent reintubation. The results from recent randomized controlled trials,&#xD;
      comparing HFNC with NIV for prevent post extubation respiratory failure among post cardiac&#xD;
      surgery and high risk patients, showed no significant different in the treatment&#xD;
      outcome.comparable with NIV among post cardiothoracic surgery and high risk for reintubated&#xD;
      patients.&#xD;
&#xD;
      About 40-85% of severe sepsis/septic shock patients developed acute respiratory failure,&#xD;
      required endotracheal intubation. According to the nature of patients population, usually&#xD;
      eldery, multiple co-morbid condition and high APACHE II score, sepsis patients were&#xD;
      considerred as high risk for reintubation, after extubated. There was no information about&#xD;
      HFNC versus NIV in prevention of reintubation among severe sepsis or septic shock patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">October 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Device failure rate</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>Device failure to prevent reintubation, patient discomfort, change to another device within 72 hours after extubation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reintubation rate</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>Patient develope respiratory failure, requiring reintubation within 72 hours after extubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>28 day mortality rate</measure>
    <time_frame>Upto 28 days</time_frame>
    <description>Proportion of dead patients to overall patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital mortality rate</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>Proportion of dead patients to overall patients from extubation to discharge date</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">222</enrollment>
  <condition>Post Extubation Respiratory Failure</condition>
  <condition>Re-intubation</condition>
  <condition>Septic Shock</condition>
  <condition>Severe Sepsis</condition>
  <arm_group>
    <arm_group_label>Noninvasive positive pressure ventilation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>After extubation, patient will receive non invasive positive pressure ventilation (NIV) for prevent respiratory and reintubation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High flow oxygen nasal cannula</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After extubation, patient will receive high flow oxygen cannula for prevent respiratory and reintubation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Noninvasive positive pressure ventilation</intervention_name>
    <description>Noninvasive positive pressure ventilation will apply via a face mask with initial setting as the following:&#xD;
Inspiratory pressure 6-8 cmH2O Expiratory pressure 3-5 cmH2O FiO2 30-60% Respiratory rate 12-16 per min</description>
    <arm_group_label>Noninvasive positive pressure ventilation</arm_group_label>
    <other_name>NIV</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High flow oxygen nasal cannula</intervention_name>
    <description>High flow oxygen nasal cannula will apply to patient via a nasal cannula with initial setting as the following:&#xD;
Temperature 37 degree celsius Flow 30 liter per min FiO2 40-60%</description>
    <arm_group_label>High flow oxygen nasal cannula</arm_group_label>
    <other_name>HFNC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of sepsis or septic shock according to the Third International Consensus&#xD;
             Definitions for Sepsis and Septic Shock (Sepsis-3)&#xD;
&#xD;
          -  Depended on mechanical ventilator for more than 48 hours&#xD;
&#xD;
          -  Plan for extubation due to successful weaning&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with tracheostomy&#xD;
&#xD;
          -  Recent upper abdominal surgery&#xD;
&#xD;
          -  Wound at face that prohibit face-mask application&#xD;
&#xD;
          -  Patient or 1st degree relative not agree to participate trial&#xD;
&#xD;
          -  Physician prefer either NIV or HFNC for the patient&#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>Surat Tongyoo, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Siriraj Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <reference>
    <citation>Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.</citation>
    <PMID>26903338</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mahidol University</investigator_affiliation>
    <investigator_full_name>Surat Tongyoo</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Sepsis</keyword>
  <keyword>Septic shock</keyword>
  <keyword>Severe sepsis</keyword>
  <keyword>Extubation</keyword>
  <keyword>Reintubation</keyword>
  <keyword>Noninvasive positive pressure ventilation</keyword>
  <keyword>High flow oxygen nasal cannula</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Toxemia</mesh_term>
    <mesh_term>Shock, Septic</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03246893
org study id: Si212/2017
nct id: NCT03246893
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Post extubation respiratory failure occur in 30% of extubated patients. More than 50% of them
      required reintubation. Noninvasive positive pressure ventilation (NIV) had been reported as
      an effective tool to prevent post extubation respiratory failure. Recently, high flow oxygen
      nasal cannula (HFNC) had been successfully used to prevent post extubation respiratory
      failure and prevent reintubation in comparable with NIV among post cardiothoracic surgery and
      high risk for reintubated patients. There was no information about HFNC versus NIV in
      prevention of reintubation among severe sepsis or septic shock patients.
Post extubation respiratory failure occur in 30% of extubated patients. More than 50% of them
      required reintubation. Noninvasive positive pressure ventilation (NIV) had been reported as
      an effective tool to prevent post extubation respiratory failure. Recently, high flow oxygen
      nasal cannula (HFNC) had been successfully used to prevent post extubation respiratory
      failure and prevent reintubation. The results from recent randomized controlled trials,
      comparing HFNC with NIV for prevent post extubation respiratory failure among post cardiac
      surgery and high risk patients, showed no significant different in the treatment
      outcome.comparable with NIV among post cardiothoracic surgery and high risk for reintubated
      patients.

      About 40-85% of severe sepsis/septic shock patients developed acute respiratory failure,
      required endotracheal intubation. According to the nature of patients population, usually
      eldery, multiple co-morbid condition and high APACHE II score, sepsis patients were
      considerred as high risk for reintubation, after extubated. There was no information about
      HFNC versus NIV in prevention of reintubation among severe sepsis or septic shock patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Device failure rate
time frame: an average of 1 year
description: Device failure to prevent reintubation, patient discomfort, change to another device within 72 hours after extubation
measure: Reintubation rate
time frame: an average of 1 year
description: Patient develope respiratory failure, requiring reintubation within 72 hours after extubation
measure: 28 day mortality rate
time frame: Upto 28 days
description: Proportion of dead patients to overall patients
measure: Hospital mortality rate
time frame: an average of 1 year
description: Proportion of dead patients to overall patients from extubation to discharge date
arm group label: Noninvasive positive pressure ventilation
arm group type: Placebo Comparator
description: After extubation, patient will receive non invasive positive pressure ventilation (NIV) for prevent respiratory and reintubation
arm group label: High flow oxygen nasal cannula
arm group type: Experimental
description: After extubation, patient will receive high flow oxygen cannula for prevent respiratory and reintubation
intervention type: Device
intervention name: Noninvasive positive pressure ventilation
description: Noninvasive positive pressure ventilation will apply via a face mask with initial setting as the following:
Inspiratory pressure 6-8 cmH2O Expiratory pressure 3-5 cmH2O FiO2 30-60% Respiratory rate 12-16 per min
arm group label: Noninvasive positive pressure ventilation
other name: NIV
intervention type: Device
intervention name: High flow oxygen nasal cannula
description: High flow oxygen nasal cannula will apply to patient via a nasal cannula with initial setting as the following:
Temperature 37 degree celsius Flow 30 liter per min FiO2 40-60%
arm group label: High flow oxygen nasal cannula
other name: HFNC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Surat Tongyoo, Dr
role: Principal Investigator
affiliation: Siriraj Hospital
facility: 
country: Thailand
citation: Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PMID: 26903338
responsible party type: Principal Investigator
investigator affiliation: Mahidol University
investigator full name: Surat Tongyoo
investigator title: Associate Professor
mesh term: Sepsis
mesh term: Toxemia
mesh term: Shock, Septic
mesh term: Respiratory Insufficiency
sharing ipd: Undecided