<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/NCT03783468</url>
  </required_header>
  <id_info>
    <org_study_id>2017_18</org_study_id>
    <secondary_id>2018-A01036-49</secondary_id>
    <nct_id>NCT03783468</nct_id>
  </id_info>
  <brief_title>LIght Sedation Pressure Support</brief_title>
  <acronym>LIPS</acronym>
  <official_title>Early LIght Sedation Pressure Support in ARDS Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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>
      Sedation may have many drawbacks in ICU patients: cardiovascular, neurologic, muscular.&#xD;
&#xD;
      Light sedation and Pressure Support ventilation is feasible in ARDS patients. However&#xD;
      spontaneous breathing can lead to high transpulmonary pressure.&#xD;
&#xD;
      The goal of the study is to measure transpulmonary pressure before sedation decrease and&#xD;
      after stabilization. The main endpoint is transpulmonary pressure less than 24 cmH2O.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    decision&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2021</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>transpulmonary pressure at early stabilization of patient</measure>
    <time_frame>when patient is conscious and stable (no modification of ventilator settings) generally within 2 hours</time_frame>
    <description>transpulmonary pressure (Paw - Peso &lt; 24 cmH2O)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>oxygenation modification</measure>
    <time_frame>stabilization of ventilator settings; 1hour after stabilization of ventilator settings</time_frame>
    <description>PaO2/FiO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>arterial pressure modification</measure>
    <time_frame>stabilization of ventilator settings; 1hour after stabilization of ventilator settings</time_frame>
    <description>Mean arterial pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate modification</measure>
    <time_frame>stabilization of ventilator settings;1hour after stabilization of ventilator settings</time_frame>
    <description>heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vasopressor dose modification</measure>
    <time_frame>stabilization of ventilator settings ; 1hour after stabilization of ventilator settings</time_frame>
    <description>vasopressor dose in norepinephrine equivalent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>acquired neuromyopathy</measure>
    <time_frame>ICU discharge, an average 16 days</time_frame>
    <description>MRC &lt;48/60</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>muscular volume decrease</measure>
    <time_frame>at 24 hours; at day of extubation; ICU discharge, an average 16 days</time_frame>
    <description>quadriceps volume assessed by echography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ventilator free days</measure>
    <time_frame>during the first 28 days</time_frame>
    <description>ventilator free days until day 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>delirium in ICU</measure>
    <time_frame>ICU discharge, an average 16 days</time_frame>
    <description>CAM-ICU is a valid and reliable delirium assessment tool recommended by the Society of Critical Care Medicine (SCCM) in its 2013 Pain, Agitation and Delirium (PAD) guidelines. the presence of delirium is confirmed in the presence of criteria 1, 2 and 3 or 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of the functional respiratory parameters from baseline at 6 months</measure>
    <time_frame>at 6 months</time_frame>
    <description>vital capacity, total pulmonary capacity,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTSD</measure>
    <time_frame>at 6 months</time_frame>
    <description>post traumatic stress disorder impact of event scale &gt; 33 tems are rated on a 5-point scale ranging from 0 (&quot;not at all&quot;) to 4 (&quot;extremely&quot;) and the total score (ranging from 0 to 88)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of auto extubation</measure>
    <time_frame>whatever until ICU discharge, an average 16 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>ARDS, Human</condition>
  <arm_group>
    <arm_group_label>light sedation pressure support ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>decrease of sedation doses and switch of ventilator settings</intervention_name>
    <description>tapering sedation doses (propofol) switch from assisted ventilation to pressure support ventilation</description>
    <arm_group_label>light sedation pressure support ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ARDS (Berlin definition)&#xD;
&#xD;
          -  social insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neuromuscular disorders&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  need for muscular paralysis&#xD;
&#xD;
          -  need for deep neurosedation&#xD;
&#xD;
          -  more than 24hrs of artificial ventilation&#xD;
&#xD;
          -  cystic fibrosis&#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>Geoffrey Ledoux, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>March 14, 2022</last_update_submitted>
  <last_update_submitted_qc>March 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</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/NCT03783468
org study id: 2017_18
secondary id: 2018-A01036-49
nct id: NCT03783468
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sedation may have many drawbacks in ICU patients: cardiovascular, neurologic, muscular.

      Light sedation and Pressure Support ventilation is feasible in ARDS patients. However
      spontaneous breathing can lead to high transpulmonary pressure.

      The goal of the study is to measure transpulmonary pressure before sedation decrease and
      after stabilization. The main endpoint is transpulmonary pressure less than 24 cmH2O.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: transpulmonary pressure at early stabilization of patient
time frame: when patient is conscious and stable (no modification of ventilator settings) generally within 2 hours
description: transpulmonary pressure (Paw - Peso < 24 cmH2O)
measure: oxygenation modification
time frame: stabilization of ventilator settings; 1hour after stabilization of ventilator settings
description: PaO2/FiO2
measure: arterial pressure modification
time frame: stabilization of ventilator settings; 1hour after stabilization of ventilator settings
description: Mean arterial pressure
measure: Heart rate modification
time frame: stabilization of ventilator settings;1hour after stabilization of ventilator settings
description: heart rate
measure: vasopressor dose modification
time frame: stabilization of ventilator settings ; 1hour after stabilization of ventilator settings
description: vasopressor dose in norepinephrine equivalent
measure: acquired neuromyopathy
time frame: ICU discharge, an average 16 days
description: MRC <48/60
measure: muscular volume decrease
time frame: at 24 hours; at day of extubation; ICU discharge, an average 16 days
description: quadriceps volume assessed by echography
measure: ventilator free days
time frame: during the first 28 days
description: ventilator free days until day 28
measure: delirium in ICU
time frame: ICU discharge, an average 16 days
description: CAM-ICU is a valid and reliable delirium assessment tool recommended by the Society of Critical Care Medicine (SCCM) in its 2013 Pain, Agitation and Delirium (PAD) guidelines. the presence of delirium is confirmed in the presence of criteria 1, 2 and 3 or 4.
measure: change of the functional respiratory parameters from baseline at 6 months
time frame: at 6 months
description: vital capacity, total pulmonary capacity,
measure: PTSD
time frame: at 6 months
description: post traumatic stress disorder impact of event scale > 33 tems are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") and the total score (ranging from 0 to 88)
measure: number of auto extubation
time frame: whatever until ICU discharge, an average 16 days
arm group label: light sedation pressure support ventilation
arm group type: Experimental
intervention type: Other
intervention name: decrease of sedation doses and switch of ventilator settings
description: tapering sedation doses (propofol) switch from assisted ventilation to pressure support ventilation
arm group label: light sedation pressure support ventilation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Geoffrey Ledoux, MD
role: Principal Investigator
affiliation: University Hospital, Lille
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome