<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/NCT03763773</url>
  </required_header>
  <id_info>
    <org_study_id>2017_30</org_study_id>
    <secondary_id>2018-A01463-52</secondary_id>
    <nct_id>NCT03763773</nct_id>
  </id_info>
  <brief_title>Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients With Acute Respiratory Distress Syndrome</brief_title>
  <acronym>PreMiTE-ARDS</acronym>
  <official_title>Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients With Acute Respiratory Distress Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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>
      The Superior Vena cava Respiratory Collapse Index (cVCS) is a haemodynamic parameter measured&#xD;
      exclusively by transoesophageal ultrasound (TEE), which is used to assess cardiac&#xD;
      precharge-dependence status. This may be an important prognostic factor in ARDS because it is&#xD;
      a sign of hypervolemia and right heart failure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 21, 2019</start_date>
  <completion_date type="Actual">April 20, 2021</completion_date>
  <primary_completion_date type="Actual">April 20, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of days lived without mechanical ventilation</measure>
    <time_frame>at 28 days</time_frame>
    <description>This variable will be defined as follows:duration = 28 -x -y. where x is the number of days living under mechanical ventilation during the first 28 days and the number of days in the first 28 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of patient of death</measure>
    <time_frame>At 28 days, at 90 days</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients with mechanical ventilation hospitalized in intensive care, emergency or intensive&#xD;
        care units&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients hospitalized in Resuscitation, Emergency or Intensive Care Units at the Roger&#xD;
             Salengro Hospital at Lille University Hospital.&#xD;
&#xD;
          -  With acute respiratory distress syndrome of intermediate or severe severity (1) for&#xD;
             less than 24 hours.&#xD;
&#xD;
          -  Mechanical ventilation with tracheal intubation or tracheostomy, in controlled&#xD;
             assisted ventilation (VAC) mode.&#xD;
&#xD;
          -  Patient adapted to mechanical ventilation (no triggering of spontaneous ventilation&#xD;
             cycle in VAC mode verified by the equality between the respiratory rate prescribed on&#xD;
             the ventilator and the actual respiratory rate of the patient).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient under extracorporeal respiratory assistance at the time of inclusion.&#xD;
&#xD;
          -  Anomalies or pathologies that make it dangerous or impossible to introduce an ETO&#xD;
             probe:&#xD;
&#xD;
               -  Fistula, perforation, stenosis, varicose vein or diverticulum of the esophagus&#xD;
                  and / or stomach&#xD;
&#xD;
               -  History of esophageal and / or gastric surgery&#xD;
&#xD;
               -  Caustic lesions of the esophagus and / stomach&#xD;
&#xD;
               -  Tumor or history of oropharyngeal surgery&#xD;
&#xD;
               -  Unstable lesions of the cervical spine&#xD;
&#xD;
               -  Coagulopathy (thrombocytopenia &lt;50 109 / L and / or TP &lt;50%).&#xD;
&#xD;
          -  Impossibility of measuring the diameter of the superior vena cava and cVCS in ETO due&#xD;
             to poor echogenicity.&#xD;
&#xD;
          -  Pregnant woman.&#xD;
&#xD;
          -  Therapeutic limitation measures limiting the treatment of organ failure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sébastien Preau, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Roger Salengro, CHU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>April 28, 2022</last_update_submitted>
  <last_update_submitted_qc>April 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>respiratory variations,</keyword>
  <keyword>superior vena cava</keyword>
  <keyword>prognosis.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Syndrome</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/NCT03763773
org study id: 2017_30
secondary id: 2018-A01463-52
nct id: NCT03763773
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Superior Vena cava Respiratory Collapse Index (cVCS) is a haemodynamic parameter measured
      exclusively by transoesophageal ultrasound (TEE), which is used to assess cardiac
      precharge-dependence status. This may be an important prognostic factor in ARDS because it is
      a sign of hypervolemia and right heart failure.
observational model: Cohort
time perspective: Prospective
measure: Number of days lived without mechanical ventilation
time frame: at 28 days
description: This variable will be defined as follows:duration = 28 -x -y. where x is the number of days living under mechanical ventilation during the first 28 days and the number of days in the first 28 days.
measure: number of patient of death
time frame: At 28 days, at 90 days
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sébastien Preau, MD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Syndrome