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Right Ventricular Dysfunction Incidence After Major Lung Resection (RESECHO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032900
Recruitment Status : Terminated
First Posted : January 26, 2017
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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

Condition or disease
Major Lung Resection Right Ventricular Dysfunction

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.

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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 : January 1, 2017
Actual Primary Completion Date : July 2, 2018
Actual Study Completion Date : July 2, 2018



Primary Outcome Measures :
  1. Right ventricular dysfunction [ Time Frame: 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 [ Time Frame: 5 days ]
    Determining risk factors for developing right ventricular failure after pulmonary resection

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

  3. Assessment of 2D strain for right ventricular dysfunctio [ Time Frame: 5 days ]
    Assessment of 2D strain for right ventricular dysfunction

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Major lung surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032900


Locations
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France
University Hospital
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03032900    
Other Study ID Numbers: UF9740
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC
Keywords provided by University Hospital, Montpellier:
Major lung resection
Right Ventricular Dysfunction
2D Strain
Additional relevant MeSH terms:
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Ventricular Dysfunction
Ventricular Dysfunction, Right
Heart Diseases
Cardiovascular Diseases