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

NCT05060302 | Unknown

• 1 other identifier: PI2021_843_0030
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Right Ventricle; Thoracic Surgery

Keywords

Right ventricle; speckle tracking; thoracic surgery

Outcome Measures

Primary Outcomes (1)

• occurrence of a major cardiovascular event (MACE)

  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.

  day 30

Secondary Outcomes (10)

• Variation of RV systolic function from baseline in patients with MACE

  at day 1

• Variation of RV systolic function from baseline in patients without MACE

  at day 1

• Variation of RV systolic function from baseline in patients with MACE

  at day 2

• Variation of RV systolic function from baseline in patients without MACE

  at day 2

• Variation of RV systolic function from baseline in patients with MACE

  at day 15

Interventions

transthoracic echocardiography (TTE) OTHER

the included patients have a TTE preoperatively in order to evaluate the RV systolic function. TTE will also be done at day 2 and day-15 during the follow-up surgical consultation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, France

RECRUITING

Central Study Contacts

Christophe Beyls, MD

CONTACT

0322087866; Beyls.Christophe@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 29, 2021
• Study Start: September 15, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)