<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/NCT03261440</url>
  </required_header>
  <id_info>
    <org_study_id>KLEIN 2016</org_study_id>
    <nct_id>NCT03261440</nct_id>
  </id_info>
  <brief_title>Cardiac, Pulmonary and Diaphragm Sonography for the Early Diagnosis of the Different Etiologies Underlying Failure of Weaning From Mechanical Ventilation</brief_title>
  <acronym>WEAN US</acronym>
  <official_title>Combined Cardiac, Pulmonary and Diaphragm Sonography for the Evaluation of Failure in Ventilation Weaning</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>
      Weaning patients off ventilation in an ICU is sometimes difficult, because of three major&#xD;
      inter-related etiologies: impaired lung, heart and diaphragm function. In this context,&#xD;
      ultrasonography during tests to wean patients off ventilation could make it possible to&#xD;
      diagnose cardiac dysfunction, a loss of pulmonary aeration or diaphragm dysfunction and thus&#xD;
      reduce the number of failures at extubation.&#xD;
&#xD;
      The study will be carried out in 100 patients on mechanical ventilation following abdominal&#xD;
      or heart surgery, who will have echocardiography, and pulmonary and diaphragm&#xD;
      ultrasonography.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Echocardiography</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Lung ultrasonography</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Diaphragm ultrasonography</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Mechanical Ventilation</condition>
  <condition>Following Heart or Abdominal Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients on post-operative mechanical ventilation following heart or abdominal surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients on mechanical ventilation for at least 48 hours&#xD;
&#xD;
          -  Age ≥ 60 years&#xD;
&#xD;
          -  Patients who have undergone abdominal or heart surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a known neuromuscular disease&#xD;
&#xD;
          -  Patients younger than 60 years&#xD;
&#xD;
          -  Duration of mechanical ventilation &lt;48h&#xD;
&#xD;
          -  Non-surgical patients&#xD;
&#xD;
          -  Patients with severe COPD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Belaïd BOUHEMAD</last_name>
    <phone>03.80.29.93.42</phone>
    <phone_ext>+33</phone_ext>
    <email>belaid.bouhemad@chu-dijon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Belaïd BOUHEMAD</last_name>
      <phone>03 80 29 93 42</phone>
      <phone_ext>+33</phone_ext>
      <email>belaid.bouhemad@chu-dijon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 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/NCT03261440
org study id: KLEIN 2016
nct id: NCT03261440
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Weaning patients off ventilation in an ICU is sometimes difficult, because of three major
      inter-related etiologies: impaired lung, heart and diaphragm function. In this context,
      ultrasonography during tests to wean patients off ventilation could make it possible to
      diagnose cardiac dysfunction, a loss of pulmonary aeration or diaphragm dysfunction and thus
      reduce the number of failures at extubation.

      The study will be carried out in 100 patients on mechanical ventilation following abdominal
      or heart surgery, who will have echocardiography, and pulmonary and diaphragm
      ultrasonography.
observational model: Other
time perspective: Prospective
measure: Echocardiography
time frame: At baseline
measure: Lung ultrasonography
time frame: At baseline
measure: Diaphragm ultrasonography
time frame: At baseline
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Belaïd BOUHEMAD
phone: 03.80.29.93.42
phone ext: +33
email: belaid.bouhemad@chu-dijon.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor