<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/NCT03032900</url>
  </required_header>
  <id_info>
    <org_study_id>UF9740</org_study_id>
    <nct_id>NCT03032900</nct_id>
  </id_info>
  <brief_title>Right Ventricular Dysfunction Incidence After Major Lung Resection</brief_title>
  <acronym>RESECHO</acronym>
  <official_title>Right Ventricular Dysfunction Incidence After Major Lung Resection, a Prospective Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to describe incidence of right ventricular dysfunction after major lung&#xD;
      resection with echocardiography criteria.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Few clinical trial studied the incidence of right ventricular dysfunction after major lung&#xD;
      resection and time frame of occurrence.&#xD;
&#xD;
      In this prospective observational study the right ventricular function will be mesure with&#xD;
      echocardiographic criteria. Echocardiographic exam will be standardised and be realised day&#xD;
      before surgery (at the same time that inclusion), day 1, day 2 and day 3 after surgery.&#xD;
&#xD;
      In order to assess prognostic value of right dysfunction after lung resection, data as&#xD;
      hospitalization stay, complications and survival will be collected at 6 months.&#xD;
&#xD;
      Cardiac cycles will be recorded and be analysed by a single observer blind to the clinical&#xD;
      finding and other echocardiographic measurements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">July 2, 2018</completion_date>
  <primary_completion_date type="Actual">July 2, 2018</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>Right ventricular dysfunction</measure>
    <time_frame>5 days</time_frame>
    <description>Without pre-existing pulmonary arteria hypertension, it will be assess with echocardiography criteria : PAPS &gt; 35mmHg or right ventricular dilatation or right systolic markers abnormalities.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk factors</measure>
    <time_frame>5 days</time_frame>
    <description>Determining risk factors for developing right ventricular failure after pulmonary resection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time frame to right ventricular dysfunction</measure>
    <time_frame>5 days</time_frame>
    <description>Time frame to right ventricular dysfunction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of 2D strain for right ventricular dysfunctio</measure>
    <time_frame>5 days</time_frame>
    <description>Assessment of 2D strain for right ventricular dysfunction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimate impact of right ventricular dysfunction on patient prognosis.</measure>
    <time_frame>5 days</time_frame>
    <description>Estimate impact of right ventricular dysfunction on patient prognosis.</description>
  </secondary_outcome>
  <enrollment type="Actual">110</enrollment>
  <condition>Major Lung Resection</condition>
  <condition>Right Ventricular Dysfunction</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Major lung surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written consent&#xD;
&#xD;
          -  Patient older than 18 years&#xD;
&#xD;
          -  Major lung surgery (pneumonectomy, lobectomy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing pulmonary arteria hypertension&#xD;
&#xD;
          -  Post-operative surgical complication on day 1 to 3 (bleeding, revision surgery)&#xD;
&#xD;
          -  Technical difficulty preventing adequate echocardiographic assessment&#xD;
&#xD;
          -  Patient refusal&#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>University Hospital</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>September 12, 2018</last_update_submitted>
  <last_update_submitted_qc>September 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Major lung resection</keyword>
  <keyword>Right Ventricular Dysfunction</keyword>
  <keyword>2D Strain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ventricular Dysfunction</mesh_term>
    <mesh_term>Ventricular Dysfunction, Right</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT03032900
org study id: UF9740
nct id: NCT03032900
lead sponsor: 
has dmc: No
This study aims to describe incidence of right ventricular dysfunction after major lung
      resection with echocardiography criteria.
Few clinical trial studied the incidence of right ventricular dysfunction after major lung
      resection and time frame of occurrence.

      In this prospective observational study the right ventricular function will be mesure with
      echocardiographic criteria. Echocardiographic exam will be standardised and be realised day
      before surgery (at the same time that inclusion), day 1, day 2 and day 3 after surgery.

      In order to assess prognostic value of right dysfunction after lung resection, data as
      hospitalization stay, complications and survival will be collected at 6 months.

      Cardiac cycles will be recorded and be analysed by a single observer blind to the clinical
      finding and other echocardiographic measurements.
observational model: Other
time perspective: Prospective
measure: Right ventricular dysfunction
time frame: 5 days
description: Without pre-existing pulmonary arteria hypertension, it will be assess with echocardiography criteria : PAPS > 35mmHg or right ventricular dilatation or right systolic markers abnormalities.
measure: Risk factors
time frame: 5 days
description: Determining risk factors for developing right ventricular failure after pulmonary resection
measure: Time frame to right ventricular dysfunction
time frame: 5 days
description: Time frame to right ventricular dysfunction
measure: Assessment of 2D strain for right ventricular dysfunctio
time frame: 5 days
description: Assessment of 2D strain for right ventricular dysfunction
measure: Estimate impact of right ventricular dysfunction on patient prognosis.
time frame: 5 days
description: Estimate impact of right ventricular dysfunction on patient prognosis.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Ventricular Dysfunction
mesh term: Ventricular Dysfunction, Right
sharing ipd: Undecided
ipd description: NC