Right Ventricular Dysfunction Incidence After Major Lung Resection (RESECHO)

Right Ventricular Dysfunction Incidence After Major Lung Resection, a Prospective Study.

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

Study Overview

• Status: Terminated
• Conditions: Right Ventricular Dysfunction; Major Lung Resection

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 Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Major lung surgery

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right ventricular dysfunction	Without pre-existing pulmonary arteria hypertension, it will be assess with echocardiography criteria : PAPS > 35mmHg or right ventricular dilatation or right systolic markers abnormalities.	5 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): July 2, 2018
• Study Completion (ACTUAL): July 2, 2018

Study Registration Dates

• First Submitted: January 16, 2017
• First Submitted That Met QC Criteria: January 23, 2017
• First Posted (ESTIMATE): January 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2018
• Last Update Submitted That Met QC Criteria: September 12, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Right Ventricular Dysfunction; Major lung resection; 2D Strain
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Right
• Other Study ID Numbers: UF9740

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC