<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/NCT01702779</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0107</org_study_id>
    <nct_id>NCT01702779</nct_id>
  </id_info>
  <brief_title>Nasal Humidified High Flow Oxygen During Weaning From Mechanical Ventilation : Ultrasonography Study</brief_title>
  <acronym>HiFloLUS</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pitié-Salpêtrière Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      This is a prospective, randomized clinical multicentric study in ICU (Intensive Care&#xD;
      University)during weaning from mechanical ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective randomized clinical multicentric study on ICU (Intensive Care University)&#xD;
      comparing nasal humidified high flow therapy versus standard oxygen with Lung Ultrasound&#xD;
      Score during weaning from mechanical ventilation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>variations of lung ultrasound score</measure>
    <time_frame>24 hours after extubation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lung ultrasound score</measure>
    <time_frame>at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rates of patients with postextubation distress</measure>
    <time_frame>during the 48th post-extubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrical Impedance tomography</measure>
    <time_frame>at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epithelial and endothelial biomarkers</measure>
    <time_frame>at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Adult Patients Ventilated More Than 48 h</condition>
  <condition>Stable Respiratory and Hemodynamic Conditions for SBT</condition>
  <condition>Consent of Patients</condition>
  <condition>Arterial Line</condition>
  <arm_group>
    <arm_group_label>optiflow</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>O2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mechanical ventilation</intervention_name>
    <description>Prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.</description>
    <arm_group_label>optiflow</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mechanical ventilation</intervention_name>
    <description>Prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.</description>
    <arm_group_label>O2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients ventilated more than 48 h&#xD;
&#xD;
          -  Stable respiratory and hemodynamic conditions for SBT&#xD;
&#xD;
          -  Consent of patients&#xD;
&#xD;
          -  Arterial line&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  COBP&#xD;
&#xD;
          -  Laryngeal dyspnea&#xD;
&#xD;
          -  Tracheostomy&#xD;
&#xD;
          -  Arythmya&#xD;
&#xD;
          -  No echogenicity&#xD;
&#xD;
          -  Paraplegia &gt;T8&#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>Sébastien PERBET</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>April 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>November 28, 2014</last_update_submitted>
  <last_update_submitted_qc>November 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Weaning from mechanical ventilation</keyword>
  <keyword>Lung ultrasound</keyword>
  <keyword>Oxygen inhalation therapy</keyword>
  <!-- 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/NCT01702779
org study id: CHU-0107
nct id: NCT01702779
lead sponsor: 
collaborator: 
This is a prospective, randomized clinical multicentric study in ICU (Intensive Care
      University)during weaning from mechanical ventilation.
Prospective randomized clinical multicentric study on ICU (Intensive Care University)
      comparing nasal humidified high flow therapy versus standard oxygen with Lung Ultrasound
      Score during weaning from mechanical ventilation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: variations of lung ultrasound score
time frame: 24 hours after extubation
measure: Lung ultrasound score
time frame: at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation
measure: rates of patients with postextubation distress
time frame: during the 48th post-extubation
measure: Electrical Impedance tomography
time frame: at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation
measure: Epithelial and endothelial biomarkers
time frame: at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation
arm group label: optiflow
arm group type: Other
arm group label: O2
arm group type: Other
intervention type: Other
intervention name: mechanical ventilation
description: Prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.
arm group label: optiflow
intervention type: Other
intervention name: mechanical ventilation
description: Prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.
arm group label: O2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sébastien PERBET
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor