Right Ventricular Dysfunction Incidence After Major Lung Resection

Right Ventricular Dysfunction Clinical Trial

— RESECHO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03032900
• Other study ID #: UF9740
• Status: Terminated
• Start date: January 1, 2017
• Est. completion date: July 2, 2018

Study information

• Verified date: September 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 110
• Est. completion date: July 2, 2018
• Est. primary completion date: July 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Major Lung Resection
• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Locations

Country	Name	City	State
France	University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

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