Right Ventricular Dysfunction Incidence After Major Lung Resection

Terminated

• Conditions: Major Lung Resection; Right Ventricular Dysfunction

• Registration Number: NCT03032900
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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

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 Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-01-16
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-26
• Primary Completion: 2018-07-02
• Study Completion: 2018-07-02
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-12
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Risk factors	5 days	Determining risk factors for developing right ventricular failure after pulmonary resection
Time frame to right ventricular dysfunction	5 days	Time frame to right ventricular dysfunction
Assessment of 2D strain for right ventricular dysfunctio	5 days	Assessment of 2D strain for right ventricular dysfunction
Estimate impact of right ventricular dysfunction on patient prognosis.	5 days	Estimate impact of right ventricular dysfunction on patient prognosis.

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Montpellier, France