<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/NCT04433325</url>
  </required_header>
  <id_info>
    <org_study_id>35RC20_3091_TOCCIP</org_study_id>
    <nct_id>NCT04433325</nct_id>
  </id_info>
  <brief_title>COVID-19 Critically Ill Patients' Evolution After Medical Transport by Train From Paris Intensive Care Units to West of France Intensive Care Units</brief_title>
  <acronym>TOCCIP</acronym>
  <official_title>COVID-19 Critically Ill Patients' Evolution After Medical Transport by Train From Paris Intensive Care Units to West of France Intensive Care Units</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      Since early 2020, France knows a sanitary crisis with a massive influx of COVID-19 patients&#xD;
      admitted in Intensive Care Units (ICU). It led to a saturation of the French health system,&#xD;
      especially in some geographic areas such as East of France or Paris region. Therefore,&#xD;
      authorities decided to transfer some critically ill patients from these crowded ICUs to less&#xD;
      busy regional ICUs. it was done for the first time by medical train transportation. Knowing&#xD;
      that the investigators lack experience regarding this type of medical evacuation, regarding&#xD;
      the high number of transferred patients, with such a logistic effort, the investigators&#xD;
      decided to study this phase of the COVID-19 sanitary crisis in order to draw a feedback. So&#xD;
      far, there are no data in the literature regarding this topic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>number of death</measure>
    <time_frame>at Intensive Care Units discharge, an average of 1 months</time_frame>
    <description>to evaluate mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of infections</measure>
    <time_frame>from date of admission until Intensive Care Units discharge, assessed up to 1 months</time_frame>
    <description>to evaluate morbidity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of days of mechanical ventilation</measure>
    <time_frame>from date of admission until Intensive Care Units discharge, assessed up to 1 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of days of sedation</measure>
    <time_frame>from date of admission until Intensive Care Units discharge, assessed up to 1 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of days of use of neuromuscular blocking agents</measure>
    <time_frame>from date of admission until Intensive Care Units discharge, assessed up to 1 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of days of vasopressor use</measure>
    <time_frame>from date of admission until Intensive Care Units discharge, assessed up to 1 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of days in Intensive Care Units</measure>
    <time_frame>from date of admission until Intensive Care Units discharge, assessed up to 1 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of days in hospital</measure>
    <time_frame>from date of admission until hospital discharge, assessed up to 1 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>COVID-19</condition>
  <condition>Intensive Care Unit Syndrome</condition>
  <arm_group>
    <arm_group_label>Patients transferred</arm_group_label>
    <description>Patients transferred from Paris's Intensive Care Units</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients not transferred</arm_group_label>
    <description>Patients admitted in Intensive Care Units with no transfer from Paris</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        COVID-19 positive patients admitted in Intensive Care Unit between 15/03/2020 and&#xD;
        15/04/2020&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  COVID-19 positive patients admitted in Intensive Care Unit between 15/03/2020 and&#xD;
             15/04/2020&#xD;
&#xD;
          -  Patients (or legal representative) with no opposition to inclusion in medical research&#xD;
             protocol&#xD;
&#xD;
          -  Regarding case group : Patients transferred from Paris's ICU&#xD;
&#xD;
          -  Regarding case control group : Patients admitted in ICU with no transfer from Paris&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - &gt; 18 years under legal protection and patients with liberty restriction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Benoît Painvin</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Rennes</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicolas Mevel</last_name>
    <phone>0299282555</phone>
    <email>dri@chu-rennes.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anne Ganivet</last_name>
    <phone>0299282555</phone>
    <email>anne.ganivet@chu-rennes.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU Poitiers</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Arnaud THILLES</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Tours</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Stéphane ERHMANN</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Medical transport by train</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/NCT04433325
org study id: 35RC20_3091_TOCCIP
nct id: NCT04433325
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Since early 2020, France knows a sanitary crisis with a massive influx of COVID-19 patients
      admitted in Intensive Care Units (ICU). It led to a saturation of the French health system,
      especially in some geographic areas such as East of France or Paris region. Therefore,
      authorities decided to transfer some critically ill patients from these crowded ICUs to less
      busy regional ICUs. it was done for the first time by medical train transportation. Knowing
      that the investigators lack experience regarding this type of medical evacuation, regarding
      the high number of transferred patients, with such a logistic effort, the investigators
      decided to study this phase of the COVID-19 sanitary crisis in order to draw a feedback. So
      far, there are no data in the literature regarding this topic.
observational model: Case-Control
time perspective: Retrospective
measure: number of death
time frame: at Intensive Care Units discharge, an average of 1 months
description: to evaluate mortality
measure: number of infections
time frame: from date of admission until Intensive Care Units discharge, assessed up to 1 months
description: to evaluate morbidity
measure: number of days of mechanical ventilation
time frame: from date of admission until Intensive Care Units discharge, assessed up to 1 months
measure: number of days of sedation
time frame: from date of admission until Intensive Care Units discharge, assessed up to 1 months
measure: number of days of use of neuromuscular blocking agents
time frame: from date of admission until Intensive Care Units discharge, assessed up to 1 months
measure: number of days of vasopressor use
time frame: from date of admission until Intensive Care Units discharge, assessed up to 1 months
measure: number of days in Intensive Care Units
time frame: from date of admission until Intensive Care Units discharge, assessed up to 1 months
measure: number of days in hospital
time frame: from date of admission until hospital discharge, assessed up to 1 months
arm group label: Patients transferred
description: Patients transferred from Paris's Intensive Care Units
arm group label: Patients not transferred
description: Patients admitted in Intensive Care Units with no transfer from Paris
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Benoît Painvin
role: Principal Investigator
affiliation: CHU Rennes
last name: Nicolas Mevel
phone: 0299282555
email: dri@chu-rennes.fr
last name: Anne Ganivet
phone: 0299282555
email: anne.ganivet@chu-rennes.fr
facility: 
contact: 
facility: 
contact: 
country: France
responsible party type: Sponsor
mesh term: COVID-19