<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/NCT04472260</url>
  </required_header>
  <id_info>
    <org_study_id>CHRO-2018-12</org_study_id>
    <nct_id>NCT04472260</nct_id>
  </id_info>
  <brief_title>Early Verticalization of the Patient With Acute Respiratory Distress Syndrome: Assessment of Feasibility and Safety.</brief_title>
  <acronym>STAND_ARDS1</acronym>
  <official_title>Early Verticalization of the Patient With Acute Respiratory Distress Syndrome: Assessment of Feasibility and Safety.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Régional d'Orléans</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Régional d'Orléans</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute Respiratory Distress Syndrome (ARDS) is defined according to the Berlin definition (1)&#xD;
      as diffuse lung damage occurring in patients with a predisposing risk factor.&#xD;
&#xD;
      Positioning in the prone position (PP) has been shown to decrease mortality in patients with&#xD;
      moderate to severe ARDS.&#xD;
&#xD;
      However, this technique is not without deleterious effects such as ventilator-associated&#xD;
      pneumonia, endotracheal tube obstruction, development of pressure ulcers, and increased&#xD;
      workload for the caregivers.&#xD;
&#xD;
      There are other positioning techniques such as the &quot;upright&quot; position, which simulates a&#xD;
      relative verticality, which allows to increase the effects of the prone position and even in&#xD;
      some patients to improve oxygenation without the PP in the acute phase of ARDS.&#xD;
&#xD;
      However, given the revolution caused by the use of PP in ARDS patients, verticalization have&#xD;
      not been studied in more details.&#xD;
&#xD;
      Today, there is a bed on the market that allows patients to be truly upright without having&#xD;
      to transfer them to a tilt table.&#xD;
&#xD;
      The investigators believe that raising ARDS patients in the acute phase is safe and feasible&#xD;
      in routine practice. In this research protocol comparing PP and verticalization in a&#xD;
      crossover trial design in acute ARDS patients, the investigators want to show that this&#xD;
      technique can be safe and feasible, with the same effects on oxygenation as PP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cross-over study, according to 4 preset sequences of 4 periods and randomly assigned. All&#xD;
      patients will thus have the classic positioning technique (PP), as well as the technique&#xD;
      under study (verticalization). For simplicity, the investigators will use the term&#xD;
      &quot;verticalization&quot; even if the final positioning that is targeted is only a&#xD;
      &quot;pseudo-verticalization&quot; to a 55° angle. The cross-over scheme with 4 sequences of 4 periods&#xD;
      allows to get rid of the first order carry-over effect.&#xD;
&#xD;
      Progressive verticalization protocol in 7 steps from the strict supine position to a 55°&#xD;
      inclination of the raising bed, according to the clinical responses of the patient with ARDS,&#xD;
      as follows:&#xD;
&#xD;
      - Verticalization in the bed&#xD;
&#xD;
      The verticalization maneuver will take place in 7 steps of 15 minutes maximum each:&#xD;
&#xD;
      S1. The first one corresponds to the flat position (strict dorsal decubitus) S2. The second&#xD;
      is the positioning of the patient at 25° of inclination. S3. The third is the 45° positioning&#xD;
      S4. The fourth at 55°, which corresponds to the greatest inclination imposed to the patient.&#xD;
&#xD;
      S5. The fifth corresponds to the 45° return S6. The sixth is the return to 25° S7. Finally,&#xD;
      the investigators reposition the patient flat back.&#xD;
&#xD;
      Examinations:&#xD;
&#xD;
        -  Arterial Gazometry At the beginning, at the end and one hour after each positioning&#xD;
           technique.&#xD;
&#xD;
        -  Chest ultrasound&#xD;
&#xD;
        -  Others All adverse events will be recorded in a clear and detailed manner.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 15, 2021</start_date>
  <completion_date type="Anticipated">October 15, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 15, 2023</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>
    <intervention_model_description>In order to compare the effect of prone position (PP) and verticalization (V) on the PaO2/FiO2 ratio (secondary objective of the study), a randomized cross-over experimental design was chosen.&#xD;
Patients will be randomly assigned to one of the following 4 sequences. They will each include 4 treatment periods:&#xD;
Sequence 1: PP-&gt;PP-&gt;V-&gt;V, Sequence 2: PP-&gt;V-&gt;V-&gt;PP, Sequence 3: V-&gt;PP-&gt;PP-&gt;V Sequence 4: V-&gt;V-&gt;PP-&gt;PP</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients who were able to reach 55° of verticalization without serious adverse events (with a complete listing of all adverse events).</measure>
    <time_frame>Month 1</time_frame>
    <description>To demonstrate the feasibility and safety in routine practice of the verticalization technique for patients with moderate to severe ARDS in the acute phase.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PaO2/FiO2 ratio at one hour from the end of the maneuver</measure>
    <time_frame>Hour 76</time_frame>
    <description>To show that verticalization of ARDS patients has the same effects on oxygenation (PaO2/FiO2 ratio) as PP.&#xD;
In this crossover trial, each sequence of four treatment periods, beginning at time of randomization, will last a maximum of 75,5 hours for each patient. The last assessment will occur at a maximum of 76,5 hours from randomisation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quasi-static compliance in (ml/cmH2O) before, at the end and one hour after each positioning technique</measure>
    <time_frame>Hour 76</time_frame>
    <description>To evaluate the impact of the positioning maneuver on quasi-static thoracopulmonary compliance.&#xD;
In this crossover trial, each sequence of four treatment periods, beginning at time of randomization, will last a maximum of 75,5 hours for each patient. The last assessment will occur at a maximum of 76,5 hours from randomisation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung Reaeration Score at 1 hour from the end of the maneuver</measure>
    <time_frame>Hour 76</time_frame>
    <description>To compare the re-ventilation of the pulmonary territories at one hour of the session (PP or verticalization) evaluated by thoracic ultrasound.&#xD;
In this crossover trial, each sequence of four treatment periods, beginning at time of randomization, will last a maximum of 75,5 hours for each patient. The last assessment will occur at a maximum of 76,5 hours from randomisation.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <condition>Prone Position</condition>
  <arm_group>
    <arm_group_label>Sequence 1: PP-&gt;PP-&gt;V-&gt;V</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS.&#xD;
The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 2: PP-&gt;V-&gt;V-&gt;PP</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS.&#xD;
The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 3: V-&gt;PP-&gt;PP-&gt;V</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS.&#xD;
The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saquence 4: V-&gt;V-&gt;PP-&gt;PP</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS.&#xD;
The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Verticalization and Prone position</intervention_name>
    <description>The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS.&#xD;
The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours.</description>
    <arm_group_label>Saquence 4: V-&gt;V-&gt;PP-&gt;PP</arm_group_label>
    <arm_group_label>Sequence 1: PP-&gt;PP-&gt;V-&gt;V</arm_group_label>
    <arm_group_label>Sequence 2: PP-&gt;V-&gt;V-&gt;PP</arm_group_label>
    <arm_group_label>Sequence 3: V-&gt;PP-&gt;PP-&gt;V</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major patient &gt; 18 years of age&#xD;
&#xD;
          -  ARDS patients with PaO2/FiO2 ratio &lt; 150 at any time within 24 hours prior to the&#xD;
             screening visit&#xD;
&#xD;
          -  Hemodynamically stable patient with mean arterial pressure (MAP) &gt; 65 mmHg maintained&#xD;
             without vasopressor or with norepinephrine at a dosage of less than 0.5 µg/kg/min.&#xD;
&#xD;
          -  Patient having already undergone at least 1 but less than 5 PP sessions&#xD;
&#xD;
          -  Patient under continuous intravenous sedation (IVSE) or not responding to simple&#xD;
             order.&#xD;
&#xD;
          -  Written consent of support person or family.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women (positive pregnancy test during screening)&#xD;
&#xD;
          -  Breastfeeding women&#xD;
&#xD;
          -  Protected Majors&#xD;
&#xD;
          -  Body weight greater than 198 kg (bed load limit)&#xD;
&#xD;
          -  Patient with one or two lower limbs amputated at the trans tibial or upper level&#xD;
&#xD;
          -  Contraindication to standing (orthopedic fracture, neurological instability with the&#xD;
             presence of an intracranial pressure sensor or an external ventricular shunt....)&#xD;
&#xD;
          -  Deep venous thrombosis of the lower limbs with curative anticoagulation for less than&#xD;
             48 hours&#xD;
&#xD;
          -  Hemodynamic instability (MAP &lt; 65 mm Hg) despite the use of norepinephrine at a dosage&#xD;
             equal or greater than 0.5 µg/kg/min.&#xD;
&#xD;
          -  Person under guardianship or trusteeship&#xD;
&#xD;
          -  Non-beneficiary patient of a health insurance plan&#xD;
&#xD;
          -  Moribund patient&#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>Mai-ANh NAY, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHR Orléans</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aurélie DESPUJOLS</last_name>
    <phone>+33238744071</phone>
    <email>aurelie.despujols@chr-orleans.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Elodie POUGOUE TOUKO</last_name>
    <phone>+33238744086</phone>
    <email>elodie.pougoue@chro-orleans.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHR d'ORLEANS</name>
      <address>
        <city>Orléans</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aurélie DESPUJOLS</last_name>
    </contact>
    <investigator>
      <last_name>May Anh NAY, PH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Umbrello M, Formenti P, Bolgiaghi L, Chiumello D. Current Concepts of ARDS: A Narrative Review. Int J Mol Sci. 2016 Dec 29;18(1):64. doi: 10.3390/ijms18010064.</citation>
    <PMID>28036088</PMID>
  </reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>December 27, 2022</last_update_submitted>
  <last_update_submitted_qc>December 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute respiratory distress syndrome</keyword>
  <keyword>Verticalization</keyword>
  <keyword>Intensive Care Unit</keyword>
  <keyword>Prone position</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>
  <!-- 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/NCT04472260
org study id: CHRO-2018-12
nct id: NCT04472260
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Acute Respiratory Distress Syndrome (ARDS) is defined according to the Berlin definition (1)
      as diffuse lung damage occurring in patients with a predisposing risk factor.

      Positioning in the prone position (PP) has been shown to decrease mortality in patients with
      moderate to severe ARDS.

      However, this technique is not without deleterious effects such as ventilator-associated
      pneumonia, endotracheal tube obstruction, development of pressure ulcers, and increased
      workload for the caregivers.

      There are other positioning techniques such as the "upright" position, which simulates a
      relative verticality, which allows to increase the effects of the prone position and even in
      some patients to improve oxygenation without the PP in the acute phase of ARDS.

      However, given the revolution caused by the use of PP in ARDS patients, verticalization have
      not been studied in more details.

      Today, there is a bed on the market that allows patients to be truly upright without having
      to transfer them to a tilt table.

      The investigators believe that raising ARDS patients in the acute phase is safe and feasible
      in routine practice. In this research protocol comparing PP and verticalization in a
      crossover trial design in acute ARDS patients, the investigators want to show that this
      technique can be safe and feasible, with the same effects on oxygenation as PP.
Cross-over study, according to 4 preset sequences of 4 periods and randomly assigned. All
      patients will thus have the classic positioning technique (PP), as well as the technique
      under study (verticalization). For simplicity, the investigators will use the term
      "verticalization" even if the final positioning that is targeted is only a
      "pseudo-verticalization" to a 55° angle. The cross-over scheme with 4 sequences of 4 periods
      allows to get rid of the first order carry-over effect.

      Progressive verticalization protocol in 7 steps from the strict supine position to a 55°
      inclination of the raising bed, according to the clinical responses of the patient with ARDS,
      as follows:

      - Verticalization in the bed

      The verticalization maneuver will take place in 7 steps of 15 minutes maximum each:

      S1. The first one corresponds to the flat position (strict dorsal decubitus) S2. The second
      is the positioning of the patient at 25° of inclination. S3. The third is the 45° positioning
      S4. The fourth at 55°, which corresponds to the greatest inclination imposed to the patient.

      S5. The fifth corresponds to the 45° return S6. The sixth is the return to 25° S7. Finally,
      the investigators reposition the patient flat back.

      Examinations:

        -  Arterial Gazometry At the beginning, at the end and one hour after each positioning
           technique.

        -  Chest ultrasound

        -  Others All adverse events will be recorded in a clear and detailed manner.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: In order to compare the effect of prone position (PP) and verticalization (V) on the PaO2/FiO2 ratio (secondary objective of the study), a randomized cross-over experimental design was chosen.
Patients will be randomly assigned to one of the following 4 sequences. They will each include 4 treatment periods:
Sequence 1: PP->PP->V->V, Sequence 2: PP->V->V->PP, Sequence 3: V->PP->PP->V Sequence 4: V->V->PP->PP
primary purpose: Other
masking: None (Open Label)
measure: Percentage of patients who were able to reach 55° of verticalization without serious adverse events (with a complete listing of all adverse events).
time frame: Month 1
description: To demonstrate the feasibility and safety in routine practice of the verticalization technique for patients with moderate to severe ARDS in the acute phase.
measure: PaO2/FiO2 ratio at one hour from the end of the maneuver
time frame: Hour 76
description: To show that verticalization of ARDS patients has the same effects on oxygenation (PaO2/FiO2 ratio) as PP.
In this crossover trial, each sequence of four treatment periods, beginning at time of randomization, will last a maximum of 75,5 hours for each patient. The last assessment will occur at a maximum of 76,5 hours from randomisation.
measure: Quasi-static compliance in (ml/cmH2O) before, at the end and one hour after each positioning technique
time frame: Hour 76
description: To evaluate the impact of the positioning maneuver on quasi-static thoracopulmonary compliance.
In this crossover trial, each sequence of four treatment periods, beginning at time of randomization, will last a maximum of 75,5 hours for each patient. The last assessment will occur at a maximum of 76,5 hours from randomisation.
measure: Lung Reaeration Score at 1 hour from the end of the maneuver
time frame: Hour 76
description: To compare the re-ventilation of the pulmonary territories at one hour of the session (PP or verticalization) evaluated by thoracic ultrasound.
In this crossover trial, each sequence of four treatment periods, beginning at time of randomization, will last a maximum of 75,5 hours for each patient. The last assessment will occur at a maximum of 76,5 hours from randomisation.
arm group label: Sequence 1: PP->PP->V->V
arm group type: Other
description: The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS.
The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours.
arm group label: Sequence 2: PP->V->V->PP
arm group type: Other
description: The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS.
The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours.
arm group label: Sequence 3: V->PP->PP->V
arm group type: Other
description: The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS.
The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours.
arm group label: Saquence 4: V->V->PP->PP
arm group type: Other
description: The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS.
The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours.
intervention type: Procedure
intervention name: Verticalization and Prone position
description: The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS.
The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours.
arm group label: Saquence 4: V->V->PP->PP
arm group label: Sequence 1: PP->PP->V->V
arm group label: Sequence 2: PP->V->V->PP
arm group label: Sequence 3: V->PP->PP->V
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mai-ANh NAY, Dr
role: Principal Investigator
affiliation: CHR Orléans
last name: Aurélie DESPUJOLS
phone: +33238744071
email: aurelie.despujols@chr-orleans.fr
last name: Elodie POUGOUE TOUKO
phone: +33238744086
email: elodie.pougoue@chro-orleans.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
citation: Umbrello M, Formenti P, Bolgiaghi L, Chiumello D. Current Concepts of ARDS: A Narrative Review. Int J Mol Sci. 2016 Dec 29;18(1):64. doi: 10.3390/ijms18010064.
PMID: 28036088
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Syndrome