<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/NCT03295357</url>
  </required_header>
  <id_info>
    <org_study_id>LAMIREL-GIRARD 2016</org_study_id>
    <nct_id>NCT03295357</nct_id>
  </id_info>
  <brief_title>Extubation of Patients on ECLS is Associated With a Reduction in Complications Related to Mechanical Ventilation: Retrospective Single-centre Study</brief_title>
  <acronym>EXTUB ECLS</acronym>
  <official_title>Extubation of Patients on ECLS is Associated With a Reduction in Complications Related to Mechanical Ventilation: Retrospective Single-centre Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</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>
      There are no clear recommendations concerning the management of patients on ECLS&#xD;
      (Extra-Corporeal Life Support). Many teams keep patients sedated until removal of the ECLS so&#xD;
      as to avoid accidents, notably decannulation. Moreover, there are few publications on the&#xD;
      subject, all the more so as the extubation of patients on ECLS (Extra-Corporeal Life Support)&#xD;
      is a recent practice. Nonetheless, it is becoming more and more frequent in the&#xD;
      cardiovascular ICU of Dijon University Hospital. We therefore wished to evaluate the benefits&#xD;
      of this practice by comparing 2 populations: those with extubation while on ECLS&#xD;
      (Extra-Corporeal Life Support) and those without.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Incidence of VAP (ventilator-associated pneumonia) during hospitalisation in the ICU</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Extra-Corporeal Life Support</condition>
  <arm_group>
    <arm_group_label>Patients with extubation while on ECLS</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients without extubation</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients on ECLS&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients over 18 years who were placed on ECLS between 1/01/14 and 31/12/15&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years old&#xD;
&#xD;
          -  Patients on ECLS for a heart transplant&#xD;
&#xD;
          -  Patients who died within the first 48 hours following the initiation of ECLS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Dijon Bourogne</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>September 25, 2017</last_update_submitted>
  <last_update_submitted_qc>September 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03295357
org study id: LAMIREL-GIRARD 2016
nct id: NCT03295357
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
There are no clear recommendations concerning the management of patients on ECLS
      (Extra-Corporeal Life Support). Many teams keep patients sedated until removal of the ECLS so
      as to avoid accidents, notably decannulation. Moreover, there are few publications on the
      subject, all the more so as the extubation of patients on ECLS (Extra-Corporeal Life Support)
      is a recent practice. Nonetheless, it is becoming more and more frequent in the
      cardiovascular ICU of Dijon University Hospital. We therefore wished to evaluate the benefits
      of this practice by comparing 2 populations: those with extubation while on ECLS
      (Extra-Corporeal Life Support) and those without.
observational model: Other
time perspective: Retrospective
measure: Incidence of VAP (ventilator-associated pneumonia) during hospitalisation in the ICU
time frame: At baseline
arm group label: Patients with extubation while on ECLS
arm group label: Patients without extubation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor