<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/NCT03835130</url>
  </required_header>
  <id_info>
    <org_study_id>18_RIPH3-06</org_study_id>
    <nct_id>NCT03835130</nct_id>
  </id_info>
  <brief_title>Pleuropulmonary Echography Versus Standard Chest X-ray in the Post-operative Follow-up of Pleuropulmonary Surgery</brief_title>
  <acronym>REC</acronym>
  <official_title>Interest of Pleuropulmonary Echography Versus Standard Chest X-ray in the Post-operative Follow-up of Pleuropulmonary Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Center of Martinique</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Center of Martinique</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>
      In postoperative pleuro-pulmonary surgery, the monitoring of the appearance of complications&#xD;
      is guided, depending on the centres, by the systematic daily performance or, in the event of&#xD;
      a call point, by chest x-ray at the patient's bed until the drains are ablative.&#xD;
&#xD;
      This repeated performance of radiographs results in irradiation of patients but also of&#xD;
      medical staff and a significant cost.&#xD;
&#xD;
      In the thoracic study, ultrasound imaging is a fast, cost-effective, non-irradiating solution&#xD;
      that can be performed at the patient's bedside. It could guide the performance of chest&#xD;
      x-ray, limit their number, with increased clinical relevance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2019</start_date>
  <completion_date type="Actual">July 23, 2019</completion_date>
  <primary_completion_date type="Actual">February 25, 2019</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of pleural disorders identified by each imaging technique</measure>
    <time_frame>between 2 and 10 days</time_frame>
    <description>Number</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of ultrasounds performed/number of chest x-ray performed</measure>
    <time_frame>one year</time_frame>
    <description>Ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of &quot;negative&quot; ultrasounds</measure>
    <time_frame>one year</time_frame>
    <description>Number</description>
  </secondary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Pleuro-pulmonary Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing pleuro-pulmonary surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with a higher age to 18 and undergoing pleuro-pulmonary surgery&#xD;
&#xD;
          -  Hospitalized patient at Martinique University Hospital&#xD;
&#xD;
          -  Patient receiving social security&#xD;
&#xD;
          -  Patient giving his free and informed consent orally&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient minor&#xD;
&#xD;
          -  Woman who is pregnant and breast feeding&#xD;
&#xD;
          -  Patient no giving his free and informed consent orally&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Nicolas VENISSAC, MD-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Martinique</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Martinique</name>
      <address>
        <city>Fort de France</city>
        <zip>97261</zip>
        <country>Martinique</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Martinique</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>October 30, 2018</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>August 7, 2019</last_update_submitted>
  <last_update_submitted_qc>August 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03835130
org study id: 18_RIPH3-06
nct id: NCT03835130
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In postoperative pleuro-pulmonary surgery, the monitoring of the appearance of complications
      is guided, depending on the centres, by the systematic daily performance or, in the event of
      a call point, by chest x-ray at the patient's bed until the drains are ablative.

      This repeated performance of radiographs results in irradiation of patients but also of
      medical staff and a significant cost.

      In the thoracic study, ultrasound imaging is a fast, cost-effective, non-irradiating solution
      that can be performed at the patient's bedside. It could guide the performance of chest
      x-ray, limit their number, with increased clinical relevance.
observational model: Cohort
time perspective: Other
measure: Number of pleural disorders identified by each imaging technique
time frame: between 2 and 10 days
description: Number
measure: Number of ultrasounds performed/number of chest x-ray performed
time frame: one year
description: Ratio
measure: Proportion of "negative" ultrasounds
time frame: one year
description: Number
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Months
maximum age: N/A
last name: Nicolas VENISSAC, MD-PhD
role: Principal Investigator
affiliation: CHU de Martinique
facility: 
country: Martinique
responsible party type: Sponsor
sharing ipd: Undecided