<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/NCT02235376</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0201</org_study_id>
    <nct_id>NCT02235376</nct_id>
  </id_info>
  <brief_title>Criteria of Extubation Failure of Brain Injured Patients. Elaboration of a Prognostic Score.</brief_title>
  <acronym>GODWEAN</acronym>
  <official_title>Criteria of Extubation Failure of Brain Injured Patients. Elaboration of a Prognostic Score.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      Identification of criteria associated with extubation failure of brain injured patients.&#xD;
      Elaboration of a prognostic score of extubation failure of brain injured patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective clinical study in ICU with brain injured ventilated patients eligible to&#xD;
      extubation.&#xD;
&#xD;
      Identification of clinical and biological criteria associated with failure of extubation.&#xD;
&#xD;
      Elaboration of a prognostic score of extubation failure of brain injured patients, based on&#xD;
      criteria previously identified with multivariate analysis.&#xD;
&#xD;
      Failure of extubation is defined by the need of re-intubation or the need for non-invasive&#xD;
      ventilation within 48 hours or more after extubation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation</measure>
    <time_frame>at day 2</time_frame>
    <description>- Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation within 48 hours or during ICU stay</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity scores (SAPS II, SOFA, GCS…) ) at patient admission in ICU</measure>
    <time_frame>at ady 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cause of brain injury (traumatic, ischemic, hemorrhagic or post-operative) at patient admission in ICU</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Localisation of brain injury (hemispheric, supra- or sub-tentorial) at patient admission in ICU</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete neurological examination (Glasgow score, Coma Recovery Scale, FOUR score, cough, brain stem reflexes) just before extubation</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiologic history (cardiac insufficiency or ischemic cardiomyopathy) during ICU stay</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>- Pulmonary examination (arterial gasometry, ventilatory parameters: mode, frequency, positive end expiratory pressure, inspiratory pressure, tidal volume, minute ventilation, oxygen level) just before extubation</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>- Cause of extubation failure before 48 hours (respiratory, hemodynamic, aspiration, ...)</measure>
    <time_frame>at day 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delay of extubation from intubation day (number of days)</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glasgow Outcome Score (GOS)</measure>
    <time_frame>at 6 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">140</enrollment>
  <condition>Brain Injury</condition>
  <arm_group>
    <arm_group_label>critical care</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>weaning trial of mechanical ventilation</intervention_name>
    <arm_group_label>critical care</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        brain injured patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult brain injured patients ventilated eligible to discontinuation of mechanical&#xD;
             ventilation&#xD;
&#xD;
          -  Stable respiratory and hemodynamic conditions&#xD;
&#xD;
          -  Ventilated patients for more than 48 hours&#xD;
&#xD;
          -  Adequate gaseous exchange (SpO2 ≥ 92% and respiratory rate ≤ 35/min, FiO2 ≤ 40%,&#xD;
             positive end-expiratory pressure ≤ 5 cmH2O, pressure support ≤ 8 cmH2O, tidal volume ≥&#xD;
             7mL/kg&#xD;
&#xD;
          -  Therapeutic extubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Status epilepticus&#xD;
&#xD;
               -  Cerebrospinal infection&#xD;
&#xD;
               -  Patients under 15 years old&#xD;
&#xD;
               -  Mechanical ventilation of &lt; 48 h&#xD;
&#xD;
               -  Spinal cord injury&#xD;
&#xD;
               -  Withdrawal of life support&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Russell CHABANNE</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>October 13, 2015</last_update_submitted>
  <last_update_submitted_qc>October 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Critical Care</keyword>
  <keyword>Brain injured patients</keyword>
  <keyword>Mechanical Ventilation</keyword>
  <keyword>Weaning</keyword>
  <keyword>Extubation</keyword>
  <keyword>Prognostic score</keyword>
  <keyword>Clinical examination</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT02235376
org study id: CHU-0201
nct id: NCT02235376
lead sponsor: 
Identification of criteria associated with extubation failure of brain injured patients.
      Elaboration of a prognostic score of extubation failure of brain injured patients.
Prospective clinical study in ICU with brain injured ventilated patients eligible to
      extubation.

      Identification of clinical and biological criteria associated with failure of extubation.

      Elaboration of a prognostic score of extubation failure of brain injured patients, based on
      criteria previously identified with multivariate analysis.

      Failure of extubation is defined by the need of re-intubation or the need for non-invasive
      ventilation within 48 hours or more after extubation.
time perspective: Prospective
measure: Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation
time frame: at day 2
description: - Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation within 48 hours or during ICU stay
measure: Severity scores (SAPS II, SOFA, GCS…) ) at patient admission in ICU
time frame: at ady 1
measure: Cause of brain injury (traumatic, ischemic, hemorrhagic or post-operative) at patient admission in ICU
time frame: at day 1
measure: Localisation of brain injury (hemispheric, supra- or sub-tentorial) at patient admission in ICU
time frame: at day 1
measure: Complete neurological examination (Glasgow score, Coma Recovery Scale, FOUR score, cough, brain stem reflexes) just before extubation
time frame: at day 1
measure: cardiologic history (cardiac insufficiency or ischemic cardiomyopathy) during ICU stay
time frame: at day 1
measure: - Pulmonary examination (arterial gasometry, ventilatory parameters: mode, frequency, positive end expiratory pressure, inspiratory pressure, tidal volume, minute ventilation, oxygen level) just before extubation
time frame: at day 1
measure: - Cause of extubation failure before 48 hours (respiratory, hemodynamic, aspiration, ...)
time frame: at day 2
measure: Delay of extubation from intubation day (number of days)
time frame: at day 1
measure: Glasgow Outcome Score (GOS)
time frame: at 6 months
arm group label: critical care
intervention type: Other
intervention name: weaning trial of mechanical ventilation
arm group label: critical care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Russell CHABANNE
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor
mesh term: Brain Injuries