<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/NCT04441736</url>
  </required_header>
  <id_info>
    <org_study_id>MS-313-2019</org_study_id>
    <nct_id>NCT04441736</nct_id>
  </id_info>
  <brief_title>Pos -Extubation High Flow Nasal Cannula</brief_title>
  <official_title>Post Extubation High Flow Nasal Cannula Versus Conventional Oxygen Therapy in Extubation Failure.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      comparing high flow nasal cannula &amp; conventional oxygen tharapy in post-extubation period for&#xD;
      patients mechanically ventilated due to respiratory failure regarding re-intubation rate, ICU&#xD;
      outcome &amp;28 days mortality&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      patients with respiratory failure either type I or type II planned for extubation will be&#xD;
      divided into 2 groups post extubation :&#xD;
&#xD;
      Group I: will receive high flow nasal cannula giving oxygen 60 litres / minute group II: will&#xD;
      receive nasal cannula up to 10 litres / minute&#xD;
&#xD;
      Data of the patients will be collected for 28 days postextubation and analysed&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 30, 2020</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 extubation respiratory failure</measure>
    <time_frame>7 days</time_frame>
    <description>Number of participants with post extubation hypoxemia with or without hypercapnea</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of ICU stay and mortality</measure>
    <time_frame>28 days</time_frame>
    <description>Duration of ICU stay and incidence of mortality</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Respiratory Insufficiency</condition>
  <arm_group>
    <arm_group_label>High flow nasal cannula</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A device og high flow nasal cannula giving 60 litres / min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional oxygen</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Nasal cannula giving oxygen up to 10 litres / minute</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High flow nasal cannula</intervention_name>
    <description>Device gives high flow oxygen comparable to non invasive ventilation</description>
    <arm_group_label>Conventional oxygen</arm_group_label>
    <arm_group_label>High flow nasal cannula</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  respiratory failure type I and Type II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mechanical ventilation due to other cause such as disturbed conscious level or&#xD;
             respiratory muscle weakness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yasser Nassar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Giza</city>
        <zip>11345</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 21, 2020</last_update_submitted>
  <last_update_submitted_qc>June 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mostafa Farouk</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04441736
org study id: MS-313-2019
nct id: NCT04441736
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
comparing high flow nasal cannula & conventional oxygen tharapy in post-extubation period for
      patients mechanically ventilated due to respiratory failure regarding re-intubation rate, ICU
      outcome &28 days mortality
patients with respiratory failure either type I or type II planned for extubation will be
      divided into 2 groups post extubation :

      Group I: will receive high flow nasal cannula giving oxygen 60 litres / minute group II: will
      receive nasal cannula up to 10 litres / minute

      Data of the patients will be collected for 28 days postextubation and analysed
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of participants with post extubation respiratory failure
time frame: 7 days
description: Number of participants with post extubation hypoxemia with or without hypercapnea
measure: Rate of ICU stay and mortality
time frame: 28 days
description: Duration of ICU stay and incidence of mortality
arm group label: High flow nasal cannula
arm group type: Active Comparator
description: A device og high flow nasal cannula giving 60 litres / min
arm group label: Conventional oxygen
arm group type: Placebo Comparator
description: Nasal cannula giving oxygen up to 10 litres / minute
intervention type: Device
intervention name: High flow nasal cannula
description: Device gives high flow oxygen comparable to non invasive ventilation
arm group label: Conventional oxygen
arm group label: High flow nasal cannula
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yasser Nassar, MD
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mostafa Farouk
investigator title: Lecturer
mesh term: Respiratory Insufficiency
sharing ipd: No