<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/NCT04438941</url>
  </required_header>
  <id_info>
    <org_study_id>7911</org_study_id>
    <nct_id>NCT04438941</nct_id>
  </id_info>
  <brief_title>Contribution of a Prone Team in Intensive Care During the Covid-19 Epidemic</brief_title>
  <acronym>COVID-PRONE</acronym>
  <official_title>Contribution of a Prone Team in Intensive Care During the Covid-19 Epidemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</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>
      SARS-CoV-2 induced by COVID 19, involved the hospitalization of 101,932 patients in France,&#xD;
      including 4,007 in intensive care (source: Santé Publique France). Alsace was one of the most&#xD;
      affected regions on the metropolitan territory with a large number of patients hospitalized&#xD;
      at the University Hospital of Strasbourg.&#xD;
&#xD;
      In view of the seriousness of the epidemic and the rapid arrival of new patients requiring&#xD;
      mechanical ventilation, 3 new intensive care units have been created on the NHC site alone,&#xD;
      making it possible to accommodate a maximum of 111 patients (compared to 52 during normal&#xD;
      periods).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 25, 2020</start_date>
  <completion_date type="Anticipated">June 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 20, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Analysis of the effect of prone position in patients with covid-19 in intensive care</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Sars-CoV2</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient hospitalized in intensive care at the NHC, diagnosed COVID + and requiring a VD&#xD;
        session&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Criteria for inclusion :&#xD;
&#xD;
          -  Major patient (≥18 years old)&#xD;
&#xD;
          -  Patient hospitalized in intensive care at the NHC, diagnosed COVID + and requiring a&#xD;
             VD session of which at least one is performed by the dedicated team.&#xD;
&#xD;
          -  patient who has not expressed, after information, his or her opposition to the re-use&#xD;
             of his or her data for the purposes of this research&#xD;
&#xD;
        Exclusion criteria :&#xD;
&#xD;
          -  Subject who expressed opposition to participating in the study&#xD;
&#xD;
          -  Subject under guardianship, curatorship or safeguarding of justice&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Bob HEGER, MD</last_name>
    <phone>33 3.69.55.04.43</phone>
    <email>Bob.Heger@chru-strasbourg.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Saïd CHAYER, PhD, HDR</last_name>
    <phone>33 3 88 11 66 90</phone>
    <email>said.chayer@chru-strasbourg.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Service d'Anesthésie-Réanimation - Nouvel Hôpital Civil</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bob HEGER, MD</last_name>
      <phone>33 3.69.55.04.43</phone>
      <email>Bob.Heger@chru-strasbourg.fr</email>
    </contact>
    <contact_backup>
      <last_name>Saïd CHAYER, PhD, HDR</last_name>
      <phone>33 3 88 11 66 90</phone>
      <email>said.chayer@chru-strasbourg.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Bob HEGER, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Olivier COLLANGE, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paul-Michel MERTES, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anne-Florence ROUBY, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nabil CHAKFE, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mechanical ventilation</keyword>
  <keyword>ICU</keyword>
  <keyword>Covid-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>ARDS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04438941
org study id: 7911
nct id: NCT04438941
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
SARS-CoV-2 induced by COVID 19, involved the hospitalization of 101,932 patients in France,
      including 4,007 in intensive care (source: Santé Publique France). Alsace was one of the most
      affected regions on the metropolitan territory with a large number of patients hospitalized
      at the University Hospital of Strasbourg.

      In view of the seriousness of the epidemic and the rapid arrival of new patients requiring
      mechanical ventilation, 3 new intensive care units have been created on the NHC site alone,
      making it possible to accommodate a maximum of 111 patients (compared to 52 during normal
      periods).
observational model: Case-Only
time perspective: Other
measure: Analysis of the effect of prone position in patients with covid-19 in intensive care
time frame: 1 month
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Bob HEGER, MD
phone: 33 3.69.55.04.43
email: Bob.Heger@chru-strasbourg.fr
last name: Saïd CHAYER, PhD, HDR
phone: 33 3 88 11 66 90
email: said.chayer@chru-strasbourg.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: COVID-19