Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery

Not Applicable

Recruiting

• Conditions: Right Ventricle; Thoracic Surgery

• Registration Number: NCT05060302
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

In postoperative thoracic surgery (lobe resection, pneumonectomy or wedge resection), cardiovascular complications are the most frequent (10 to 15%) with a significant morbi-mortality rate. Right ventricular (RV) dysfunction is a complication that can be multifactorial in post thoracic surgery. The RV longitudinal shortening fraction (RV-LSF) is a new 2D-STE parameters able to more accurately detect patients with RV dysfunction compared to conventional echocardiographic parameters.

This project is a single-center, prospective, interventional study of patients hospitalized at the Amiens University Hospital for scheduled thoracic surgery. TTE is performed preoperatively, at day 2 and day 15 following the thoracic surgery. Echocardiographic parameters will be measured by an echocardiographic expert in offline with a dedicated software. MACE criteria will be collected at day 2, day 15 and day-30 following the thoracic surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-15
• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-24
• Study First Posted: 2021-09-29
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• Adult patient (>18 years)
• Patient hospitalized at the Amiens University Hospital for scheduled thoracic surgery (lobectomy, pneumonectomy, wedge resection).
• Surgery by thoracotomy or video-assisted thoracic surgery
• Information of the patient and collection of his non-opposition

Exclusion Criteria

• Patient with poor echogenicity on TTE not allowing evaluation of 2D-STE or conventional parameters of the RV.
• Patient with a rapid supraventricular rhythm disorder (HR > 100) at the time of TTE
• Patient under mechanical ventilation
• Patient under extracorporeal membrane oxygenation
• Patients under guardianship or legal protection
• Patients whose clinical condition does not allow for their non-opposition
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
occurrence of a major cardiovascular event (MACE)	day 30	MACE is a composite criteria. MACES criteria is defined as the occurrence of at least one of the following events: A cardiovascular death or a documented supraventricular tachycardia (atrial fibrillation and/or flutter) of duration \> 30 seconds or, an acute myocardial infarction or, an hospitalization for a right ventricular failure or, an hospitalization for a left ventricular failure.

Secondary Outcome Measures

Name	Time	Method
Variation of RV systolic function from baseline in patients without MACE	within day 30
Variation of RV systolic function from baseline in patients with MACE	within day 30
occurrence of a postoperative complication	at day 30
Assessment of RV systolic function preoperatively	at day 30

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, France