<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/NCT04420286</url>
  </required_header>
  <id_info>
    <org_study_id>30RC20_0117</org_study_id>
    <nct_id>NCT04420286</nct_id>
  </id_info>
  <brief_title>Study of the Increase in ICU Beds Capacity During COVID-19 Pandemic in France</brief_title>
  <acronym>FRENCH ICU</acronym>
  <official_title>Study of the Increase in ICU Beds Capacity and Caregivers During COVID-19 Pandemic in France : the FRENCH ICU Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</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>
      For preventing the overwhelming of ICU beds capacity during COVID-19 pandemic in France,&#xD;
      national and regional Health-Care institutions decided to optimize the Intensive Care Unit&#xD;
      beds availability by opening new ICU beds in institutions with and without prior ICU. The&#xD;
      Present study was design to retrospectively describe the origin of the ICU beds and human&#xD;
      resources created during the COVID-19 outbreak in France.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since December 2019, the SARS-CoV-2 coronavirus disease has caused a worldwide outbreak of&#xD;
      respiratory illness that rapidly invaded leading the world (WHO). Its most severe form is&#xD;
      dominated by an acute respiratory distress syndrome (ARDS) with other organ failures&#xD;
      requiring mechanical ventilation and admission in Intensive Care Unit (ICU). With a wide&#xD;
      pandemic effect and a long length of mechanical ventilation, the intensive care units were&#xD;
      quickly full.&#xD;
&#xD;
      For preventing the overwhelming of ICU beds capacity, national and regional Health-Care&#xD;
      institutions (then French Health minister, every Regional Health) decided to optimize the&#xD;
      Intensive Care Unit beds availability by opening new ICU beds in institutions with and&#xD;
      without prior ICU.&#xD;
&#xD;
      Daily ICU beds availability was assessed in each institution, and at the regional level to&#xD;
      organize potential patient transfers across regional and national hospital. Moreover, an&#xD;
      extraordinary mobilization and joint efforts of medical, paramedical and administrative staff&#xD;
      allowed getting the caregivers for managing the most severe patients in each ICU. All&#xD;
      physicians who could manage ICU patients were involved in this crisis. In this context,&#xD;
      anesthesiologists (who have gotten an ICU education during their studies) were involved, as&#xD;
      the surgical activity has been reduced to the vital procedures. This overall organization&#xD;
      permitted the admission of more patients than the initial maximum national capacity of ICU&#xD;
      beds.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 6, 2020</start_date>
  <completion_date type="Actual">June 12, 2020</completion_date>
  <primary_completion_date type="Actual">June 12, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>origin of the ICU beds created during the COVID-19 outbreak in France.</measure>
    <time_frame>DAY 0</time_frame>
    <description>Describe the origin of the ICU beds created during the COVID-19 outbreak in France.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Human Resources</measure>
    <time_frame>DAY 0</time_frame>
    <description>Describe the human resources (medical and non-medical) mobilized to ensure that all acute patients could be managed (physicians according to their initial specialty, nurses and nursing auxiliaries).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">9860</enrollment>
  <condition>Coronavirus Infections</condition>
  <condition>COVID19 Outbreak in France</condition>
  <arm_group>
    <arm_group_label>Hospital having ICU beds</arm_group_label>
    <description>Hospital having ICU beds during COVID-19 outbreak in France</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study is not based on patients but on hospital organisation to describe the origin of&#xD;
        the ICU beds and human resources created during the COVID-19 outbreak in France.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospital having ICU during COVID-19 outbreak in France&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hospital refuse to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Nîmes, Hôpital Universitaire Carémeau</name>
      <address>
        <city>Nimes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Critical care</keyword>
  <keyword>Intensive Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</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/NCT04420286
org study id: 30RC20_0117
nct id: NCT04420286
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
For preventing the overwhelming of ICU beds capacity during COVID-19 pandemic in France,
      national and regional Health-Care institutions decided to optimize the Intensive Care Unit
      beds availability by opening new ICU beds in institutions with and without prior ICU. The
      Present study was design to retrospectively describe the origin of the ICU beds and human
      resources created during the COVID-19 outbreak in France.
Since December 2019, the SARS-CoV-2 coronavirus disease has caused a worldwide outbreak of
      respiratory illness that rapidly invaded leading the world (WHO). Its most severe form is
      dominated by an acute respiratory distress syndrome (ARDS) with other organ failures
      requiring mechanical ventilation and admission in Intensive Care Unit (ICU). With a wide
      pandemic effect and a long length of mechanical ventilation, the intensive care units were
      quickly full.

      For preventing the overwhelming of ICU beds capacity, national and regional Health-Care
      institutions (then French Health minister, every Regional Health) decided to optimize the
      Intensive Care Unit beds availability by opening new ICU beds in institutions with and
      without prior ICU.

      Daily ICU beds availability was assessed in each institution, and at the regional level to
      organize potential patient transfers across regional and national hospital. Moreover, an
      extraordinary mobilization and joint efforts of medical, paramedical and administrative staff
      allowed getting the caregivers for managing the most severe patients in each ICU. All
      physicians who could manage ICU patients were involved in this crisis. In this context,
      anesthesiologists (who have gotten an ICU education during their studies) were involved, as
      the surgical activity has been reduced to the vital procedures. This overall organization
      permitted the admission of more patients than the initial maximum national capacity of ICU
      beds.
observational model: Other
time perspective: Retrospective
measure: origin of the ICU beds created during the COVID-19 outbreak in France.
time frame: DAY 0
description: Describe the origin of the ICU beds created during the COVID-19 outbreak in France.
measure: Human Resources
time frame: DAY 0
description: Describe the human resources (medical and non-medical) mobilized to ensure that all acute patients could be managed (physicians according to their initial specialty, nurses and nursing auxiliaries).
arm group label: Hospital having ICU beds
description: Hospital having ICU beds during COVID-19 outbreak in France
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Coronavirus Infections
sharing ipd: No