<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/NCT03281473</url>
  </required_header>
  <id_info>
    <org_study_id>49RC17_0220</org_study_id>
    <nct_id>NCT03281473</nct_id>
  </id_info>
  <brief_title>Comparison of Positive End Expiratory Pressure Titration Methods in ARDS Patients</brief_title>
  <acronym>ELSE</acronym>
  <official_title>Comparison of Positive End Expiratory Pressure Titration Methods in Patients With Acute Respiratory Distress Syndrome: a Physiological Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</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>
      This study aims at assessing the short-term physiological effects of 2 positive end&#xD;
      expiratory pressure titration strategies in patients with ARDS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 2, 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Short-term effects of 2 PEEP titration strategies on gas exchange</measure>
    <time_frame>2 hours 15 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short-term effects of 2 PEEP titration strategies on respiratory mechanics</measure>
    <time_frame>2 hours 15 min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short-term effects of 2 PEEP titration strategies on hemodynamics</measure>
    <time_frame>2 hours 15 min</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>Arms A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Strategy 1 - Washout period - Strategy 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arms B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Strategy 2 - Washout period - Strategy 1</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Strategy 1</intervention_name>
    <description>PEEP titration according to transpulmonary-end-expiratory pressure</description>
    <arm_group_label>Arms A</arm_group_label>
    <arm_group_label>Arms B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Strategy 2</intervention_name>
    <description>PEEP titration according to chest wall elastance measurement</description>
    <arm_group_label>Arms A</arm_group_label>
    <arm_group_label>Arms B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt; 18 years&#xD;
&#xD;
          -  Moderate or severe ARDS&#xD;
&#xD;
          -  Consent to participation obtained from a relative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Protect adult&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
&#xD;
          -  No-affiliation to the social security scheme&#xD;
&#xD;
          -  Contra-indication to the placement of an esophageal pressure measuring catheter&#xD;
&#xD;
          -  Pneumothorax&#xD;
&#xD;
          -  Hemodynamic and / or respiratory instability&#xD;
&#xD;
          -  Extra-corporeal membrane oxygenation&#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>Study Official is required by the WHO and BELONCLE, Ass.Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Angers teatching hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Study Official is required by the WHO and BELONCLE, Ass.Pr</last_name>
    <phone>0241353845</phone>
    <email>Francois.Beloncle@chu-angers.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>François BELONCLE, Ass.Pr</last_name>
      <phone>0241353845</phone>
      <email>Francois.Beloncle@chu-angers.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>March 19, 2019</last_update_submitted>
  <last_update_submitted_qc>March 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ARDS</keyword>
  <keyword>Esophageal pressure</keyword>
  <keyword>Mechanical ventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Syndrome</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/NCT03281473
org study id: 49RC17_0220
nct id: NCT03281473
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims at assessing the short-term physiological effects of 2 positive end
      expiratory pressure titration strategies in patients with ARDS.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Short-term effects of 2 PEEP titration strategies on gas exchange
time frame: 2 hours 15 minutes
measure: Short-term effects of 2 PEEP titration strategies on respiratory mechanics
time frame: 2 hours 15 min
measure: Short-term effects of 2 PEEP titration strategies on hemodynamics
time frame: 2 hours 15 min
arm group label: Arms A
arm group type: Experimental
description: Strategy 1 - Washout period - Strategy 2
arm group label: Arms B
arm group type: Experimental
description: Strategy 2 - Washout period - Strategy 1
intervention type: Other
intervention name: Strategy 1
description: PEEP titration according to transpulmonary-end-expiratory pressure
arm group label: Arms A
arm group label: Arms B
intervention type: Other
intervention name: Strategy 2
description: PEEP titration according to chest wall elastance measurement
arm group label: Arms A
arm group label: Arms B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Study Official is required by the WHO and BELONCLE, Ass.Pr
role: Principal Investigator
affiliation: Angers teatching hospital
last name: Study Official is required by the WHO and BELONCLE, Ass.Pr
phone: 0241353845
email: Francois.Beloncle@chu-angers.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Syndrome
sharing ipd: No