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RESECHO: Right Ventricular Dysfunction Incidence After Major Lung Resection

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Terminated
CT.gov ID
NCT03032900
Collaborator
(none)
110
Enrollment
1
Location
18
Actual Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to describe incidence of right ventricular dysfunction after major lung resection with echocardiography criteria.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    110 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Right Ventricular Dysfunction Incidence After Major Lung Resection, a Prospective Study.
    Actual Study Start Date :
    Jan 1, 2017
    Actual Primary Completion Date :
    Jul 2, 2018
    Actual Study Completion Date :
    Jul 2, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Right ventricular dysfunction [5 days]

      Without pre-existing pulmonary arteria hypertension, it will be assess with echocardiography criteria : PAPS > 35mmHg or right ventricular dilatation or right systolic markers abnormalities.

    Secondary Outcome Measures

    1. Risk factors [5 days]

      Determining risk factors for developing right ventricular failure after pulmonary resection

    2. Time frame to right ventricular dysfunction [5 days]

      Time frame to right ventricular dysfunction

    3. Assessment of 2D strain for right ventricular dysfunctio [5 days]

      Assessment of 2D strain for right ventricular dysfunction

    4. Estimate impact of right ventricular dysfunction on patient prognosis. [5 days]

      Estimate impact of right ventricular dysfunction on patient prognosis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Written consent

    • Patient older than 18 years

    • Major lung surgery (pneumonectomy, lobectomy)

    Exclusion Criteria:

    • Pre-existing pulmonary arteria hypertension

    • Post-operative surgical complication on day 1 to 3 (bleeding, revision surgery)

    • Technical difficulty preventing adequate echocardiographic assessment

    • Patient refusal

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT03032900
    Other Study ID Numbers:
    • UF9740
    First Posted:
    Jan 26, 2017
    Last Update Posted:
    Sep 14, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by University Hospital, Montpellier
    Major lung resection
    Right Ventricular Dysfunction
    2D Strain
    Additional relevant MeSH terms:
    Ventricular Dysfunction
    Ventricular Dysfunction, Right

    Study Results

    No Results Posted as of Sep 14, 2018