<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/NCT02979652</url>
  </required_header>
  <id_info>
    <org_study_id>00010254-2016 -016</org_study_id>
    <nct_id>NCT02979652</nct_id>
  </id_info>
  <brief_title>Can Point of Care Chest Ultrasound Predicts Pulmonary Complications After Major Surgery?</brief_title>
  <acronym>POCUSR</acronym>
  <official_title>Can Point of Care Chest Ultrasound Predicts Pulmonary Complications After Major Surgery?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Nord</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Nord</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is done to estimate prevalence of the main detectable lung and cardiovascular&#xD;
      complications by an ultrasound realized in room of post-interventional supervision at the&#xD;
      patients whose duration of general anesthesia is superior at one hour after a surgery to risk&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2016</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>8 Days</target_duration>
  <primary_outcome>
    <measure>cardiac and pulmonary functions</measure>
    <time_frame>1 hour</time_frame>
    <description>cardiac and pulmonary functions will be evaluated by cardiac and pulmonary ultrasound exams for all patient whom have a more than 1 hour surgical intervention</description>
  </primary_outcome>
  <enrollment type="Anticipated">325</enrollment>
  <condition>Intensive Care, Surgical</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients hospatilized for a major surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physical status score &gt; 1&#xD;
&#xD;
          -  Anesthesia of duration &gt; 1 hour&#xD;
&#xD;
          -  Visceral, orthopaedic, vascular, thoracic surgery, neurosurgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Technical incapacity of accessibility to the ultrasound window&#xD;
&#xD;
          -  Cardiac or pulmonary transplant&#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>Marc Leone, MD</last_name>
    <role>Study Director</role>
    <affiliation>Departement anesthesie reanimation hopital nord</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marc Leone, M.D</last_name>
    <email>mleone@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Departement anesthesie reanimation hopital nord</name>
      <address>
        <city>Marseille</city>
        <zip>13015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marc Leone, MD</last_name>
      <email>mleone@ap-hm.fr</email>
    </contact>
    <contact_backup>
      <last_name>laurent Zieleskiewicz, MD</last_name>
      <email>lZieleskiewicz@ap-hm.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>November 30, 2016</last_update_submitted>
  <last_update_submitted_qc>November 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02979652
org study id: 00010254-2016 -016
nct id: NCT02979652
lead sponsor: 
has dmc: No
This study is done to estimate prevalence of the main detectable lung and cardiovascular
      complications by an ultrasound realized in room of post-interventional supervision at the
      patients whose duration of general anesthesia is superior at one hour after a surgery to risk
observational model: Cohort
time perspective: Prospective
measure: cardiac and pulmonary functions
time frame: 1 hour
description: cardiac and pulmonary functions will be evaluated by cardiac and pulmonary ultrasound exams for all patient whom have a more than 1 hour surgical intervention
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc Leone, MD
role: Study Director
affiliation: Departement anesthesie reanimation hopital nord
last name: Marc Leone, M.D
email: mleone@ap-hm.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
sharing ipd: No