<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/NCT03289975</url>
  </required_header>
  <id_info>
    <org_study_id>DRANSART BOUHEMAD 2016</org_study_id>
    <nct_id>NCT03289975</nct_id>
  </id_info>
  <brief_title>Early Identification of Patients in Surgical Intensive Care With a Risk of Acute Respiratory Distress Following Visceral Surgery</brief_title>
  <acronym>ODR</acronym>
  <official_title>Early Identification of Patients in Surgical Intensive Care With a Risk of Acute Respiratory Distress Following Visceral Surgery: Prognostic Value of Pulmonary Extravascular Water Revealed by Pulmonary Ultrasound.</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>
      Today there are few studies in the literature involving patients in an ICU following major&#xD;
      visceral surgery. There are thus few results about the prognostic value of pulmonary&#xD;
      extravascular water in this population of patients, but also the prognostic value of&#xD;
      pulmonary extravascular water measured at the bedside using pulmonary ultrasound.&#xD;
&#xD;
      In addition, pulmonary ultrasound will be combined with echocardiography to measure left&#xD;
      ventricular function (LVEF) and to study the profile of the mitral valve to assess filling&#xD;
      pressure in patients with immediate post-operative ventilation. This will make it possible to&#xD;
      distinguish between increases in pulmonary extravascular water associated with high filling&#xD;
      pressure and increased pulmonary water associated with low filling pressure: characteristic&#xD;
      of lesional oedema.&#xD;
&#xD;
      The aim of this study is to determine the prognostic value of extravascular pulmonary water&#xD;
      (PEVW) diagnosed using pulmonary ultrasound in patients admitted to an ICU following&#xD;
      scheduled or emergency visceral surgery in the onset of acute respiratory distress requiring&#xD;
      invasive mechanical ventilation, or prolonged post-operative intubation, or non-invasive.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2016</start_date>
  <completion_date type="Actual">March 29, 2017</completion_date>
  <primary_completion_date type="Actual">March 29, 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>Onset of post-operative acute respiratory distress</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <enrollment type="Actual">165</enrollment>
  <condition>Digestive Surgery</condition>
  <condition>Urinary Surgery</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pulmonary ultrasound</intervention_name>
    <description>Collect the aeration profile for each lung quadrant: profile A, profile B1, profile B2, profile C. Calculate the aeration score from O to 36 (LUS (Lung ultrasound) score).</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing digestive or urinary surgery and requiring post-operative intensive&#xD;
        care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients undergoing scheduled or emergency visceral surgery and admitted to an ICU&#xD;
        following the intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chest surgery&#xD;
&#xD;
          -  ASA (American Society of Anesthesiologists) 4 or more&#xD;
&#xD;
          -  Refusal of the patient&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Spontaneously-breathing patients&#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 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 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/NCT03289975
org study id: DRANSART BOUHEMAD 2016
nct id: NCT03289975
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Today there are few studies in the literature involving patients in an ICU following major
      visceral surgery. There are thus few results about the prognostic value of pulmonary
      extravascular water in this population of patients, but also the prognostic value of
      pulmonary extravascular water measured at the bedside using pulmonary ultrasound.

      In addition, pulmonary ultrasound will be combined with echocardiography to measure left
      ventricular function (LVEF) and to study the profile of the mitral valve to assess filling
      pressure in patients with immediate post-operative ventilation. This will make it possible to
      distinguish between increases in pulmonary extravascular water associated with high filling
      pressure and increased pulmonary water associated with low filling pressure: characteristic
      of lesional oedema.

      The aim of this study is to determine the prognostic value of extravascular pulmonary water
      (PEVW) diagnosed using pulmonary ultrasound in patients admitted to an ICU following
      scheduled or emergency visceral surgery in the onset of acute respiratory distress requiring
      invasive mechanical ventilation, or prolonged post-operative intubation, or non-invasive.
observational model: Other
time perspective: Prospective
measure: Onset of post-operative acute respiratory distress
time frame: 28 days
intervention type: Other
intervention name: pulmonary ultrasound
description: Collect the aeration profile for each lung quadrant: profile A, profile B1, profile B2, profile C. Calculate the aeration score from O to 36 (LUS (Lung ultrasound) score).
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