<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/NCT01695603</url>
  </required_header>
  <id_info>
    <org_study_id>Intellibrain</org_study_id>
    <nct_id>NCT01695603</nct_id>
  </id_info>
  <brief_title>Comparison of a New Automated Ventilatory Mode Named Intellivent to Standard Controlled Ventilation in Brain Injured Patients</brief_title>
  <official_title>Comparison of a New Automated Ventilatory Mode Named Intellivent to Standard Controlled Ventilation in Brain Injured Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Philippe Jolliet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Lausanne Hospitals</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Lausanne Hospitals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison of the ability of a new automated ventilatory mode named Intellibrain to maintain&#xD;
      capnia and oxgen partial pressure within predefined ranges in comparison to the control of&#xD;
      capnia and oxgen partial pressure obtained by using standard controlled ventilation modes in&#xD;
      brain injured patients. Comparison of the numbers of alarms and required settings&#xD;
      modifications observed with each ventilatory mode.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Partial pressure of carbon dioxide</measure>
    <description>The partial pressure of carbon dioxide (PaCO2) will be recorded every thirty minutes during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Partial pressure of oxygen</measure>
    <description>The partial pressure of oxygen (PaCO2) will be recorded every thirty minutes during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of alarms generated by the ventilator</measure>
    <description>The number of alarms generated by the ventilator will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of settings modifications</measure>
    <description>The number of ventilator settings modifications required will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intracranial pressure</measure>
    <description>Intracranial pressure will be recorded continuously during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory parameters</measure>
    <description>Various respiratory parameters tidal volume, respiratory rate, minute ventilation, airway pressure) will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral vasoreactivity</measure>
    <description>Cerebral vasoreactivity will be studied from the intracranial pressure and invasive arterial pressure curves recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial pressure of oxygen in the brain tissue if available</measure>
    <description>Partial pressure of oxygen in the brain tissue, if available for clinical reasons, will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of therapeutic actions needed to reduce intracranial pressure</measure>
    <description>The number of therapeutic actions needed to reduce intracranial pressure will be recorded during two hours under standard controlled ventilation and during two hours under Intellivent ventilation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral perfusion pressure</measure>
    <description>Cerebral perfusion pressure will be recorded continuously during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Brain Injured Patients</condition>
  <arm_group>
    <arm_group_label>Standard mode of controlled ventilation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Each brain injured patient will be ventilated during two hours with a standard mode of controlled ventilation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intellivent arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each brain injured patient will be ventilated during two hours with an automated mode of ventilation, the Intellivent mode.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intellivent</intervention_name>
    <arm_group_label>Intellivent arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Brain injury ( traumatic brain injury, subarachnoi8dal haemorrhage, intracerebral&#xD;
             hemorrhage, ischemic stroke)&#xD;
&#xD;
          -  Glasgow coma scale of 9 or less&#xD;
&#xD;
          -  Controlled mechanical ventilation required&#xD;
&#xD;
          -  Intracranial pressure monitoring required for clinical reasons&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age under 16 years old&#xD;
&#xD;
          -  clinical signs of brainstem lesions&#xD;
&#xD;
          -  patients with withdrawal order or for whom organ donation is under discussion&#xD;
&#xD;
          -  major haemodynamic instability&#xD;
&#xD;
          -  High carbon dioxide alveoloarterial gradient (&gt;10 mmHg) and/or suffering of severe&#xD;
             hypoxemia (PaO2/FIO2 &lt; 150 mmHg)&#xD;
&#xD;
          -  Patients included in another interventional clinical study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe Jolliet, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Lausanne Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Adult Intensive Care and Burn Unit, University hospital of Lausanne</name>
      <address>
        <city>Lausanne</city>
        <zip>1012</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>May 3, 2017</last_update_submitted>
  <last_update_submitted_qc>May 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Lausanne Hospitals</investigator_affiliation>
    <investigator_full_name>Prof. Philippe Jolliet</investigator_full_name>
    <investigator_title>Main investigator</investigator_title>
  </responsible_party>
  <keyword>Brain injury</keyword>
  <keyword>Controlled ventilation</keyword>
  <keyword>Intellivent</keyword>
  <keyword>Capnia control</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/NCT01695603
org study id: Intellibrain
nct id: NCT01695603
lead sponsor: 
collaborator: 
has dmc: No
Comparison of the ability of a new automated ventilatory mode named Intellibrain to maintain
      capnia and oxgen partial pressure within predefined ranges in comparison to the control of
      capnia and oxgen partial pressure obtained by using standard controlled ventilation modes in
      brain injured patients. Comparison of the numbers of alarms and required settings
      modifications observed with each ventilatory mode.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Partial pressure of carbon dioxide
description: The partial pressure of carbon dioxide (PaCO2) will be recorded every thirty minutes during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
measure: Partial pressure of oxygen
description: The partial pressure of oxygen (PaCO2) will be recorded every thirty minutes during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
measure: Number of alarms generated by the ventilator
description: The number of alarms generated by the ventilator will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
measure: Number of settings modifications
description: The number of ventilator settings modifications required will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
measure: Intracranial pressure
description: Intracranial pressure will be recorded continuously during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
measure: Respiratory parameters
description: Various respiratory parameters tidal volume, respiratory rate, minute ventilation, airway pressure) will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
measure: Cerebral vasoreactivity
description: Cerebral vasoreactivity will be studied from the intracranial pressure and invasive arterial pressure curves recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
measure: Partial pressure of oxygen in the brain tissue if available
description: Partial pressure of oxygen in the brain tissue, if available for clinical reasons, will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
measure: Number of therapeutic actions needed to reduce intracranial pressure
description: The number of therapeutic actions needed to reduce intracranial pressure will be recorded during two hours under standard controlled ventilation and during two hours under Intellivent ventilation.
measure: Cerebral perfusion pressure
description: Cerebral perfusion pressure will be recorded continuously during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
arm group label: Standard mode of controlled ventilation
arm group type: No Intervention
description: Each brain injured patient will be ventilated during two hours with a standard mode of controlled ventilation.
arm group label: Intellivent arm
arm group type: Experimental
description: Each brain injured patient will be ventilated during two hours with an automated mode of ventilation, the Intellivent mode.
intervention type: Device
intervention name: Intellivent
arm group label: Intellivent arm
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Philippe Jolliet, Prof
role: Principal Investigator
affiliation: University of Lausanne Hospitals
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: University of Lausanne Hospitals
investigator full name: Prof. Philippe Jolliet
investigator title: Main investigator