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

Thoracic Surgery Clinical Trial

— SPECKLETHO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05060302
• Other study ID #: PI2021_843_0030
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: September 2024

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Christophe Beyls, MD
• Phone: 0322087866
• Email: Beyls.Christophe[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Right Ventricle
• Thoracic Surgery
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

Other:
• transthoracic echocardiography (TTE)
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.

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Variation of RV systolic function from baseline in patients with MACE		at day 1
Secondary	Variation of RV systolic function from baseline in patients without MACE		at day 1
Secondary	Variation of RV systolic function from baseline in patients with MACE		at day 2
Secondary	Variation of RV systolic function from baseline in patients without MACE		at day 2
Secondary	Variation of RV systolic function from baseline in patients with MACE		at day 15
Secondary	Variation of RV systolic function from baseline in patients without MACE		at day 15
Secondary	Variation of RV systolic function from baseline in patients with MACE		within day 30
Secondary	Variation of RV systolic function from baseline in patients without MACE		within day 30
Secondary	Assessment of RV systolic function preoperatively		at day 30
Secondary	occurrence of a postoperative complication		at day 30