Clinical trial NCT05060302: Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery
Official title: Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Right Ventricle
Thoracic Surgery
Keywords: Right ventricle
speckle tracking
thoracic surgery
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: occurrence of a major cardiovascular event (MACE)
timeFrame: day 30
Secondary outcomes:
measure: Variation of RV systolic function from baseline in patients with MACE
timeFrame: at day 1
measure: Variation of RV systolic function from baseline in patients without MACE
timeFrame: at day 1
measure: Variation of RV systolic function from baseline in patients with MACE
timeFrame: at day 2
measure: Variation of RV systolic function from baseline in patients without MACE
timeFrame: at day 2
measure: Variation of RV systolic function from baseline in patients with MACE
timeFrame: at day 15
measure: Variation of RV systolic function from baseline in patients without MACE
timeFrame: at day 15
measure: Variation of RV systolic function from baseline in patients with MACE
timeFrame: within day 30
measure: Variation of RV systolic function from baseline in patients without MACE
timeFrame: within day 30
measure: Assessment of RV systolic function preoperatively
timeFrame: at day 30
measure: occurrence of a postoperative complication
timeFrame: at day 30
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
References: