Skip to main content
Clinical Trials/NCT05060302
NCT05060302
Recruiting
Not Applicable

Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery: a Pilot Study

Centre Hospitalier Universitaire, Amiens1 site in 1 country164 target enrollmentSeptember 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Right Ventricle
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
164
Locations
1
Primary Endpoint
occurrence of a major cardiovascular event (MACE)
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 15, 2021
End Date
September 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

occurrence of a major cardiovascular event (MACE)

Time Frame: 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 Outcomes

  • Variation of RV systolic function from baseline in patients with MACE(within day 30)
  • occurrence of a postoperative complication(at day 30)
  • Variation of RV systolic function from baseline in patients without MACE(within day 30)
  • Assessment of RV systolic function preoperatively(at day 30)

Study Sites (1)

Loading locations...

Similar Trials