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

February 7, 2023 updated by: Centre Hospitalier Universitaire, Amiens

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Recruiting
        • CHU Amiens Picardie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day 30

Secondary Outcome Measures

Outcome Measure
Time Frame
Variation of RV systolic function from baseline in patients with MACE
Time Frame: at day 1
at day 1
Variation of RV systolic function from baseline in patients without MACE
Time Frame: at day 1
at day 1
Variation of RV systolic function from baseline in patients with MACE
Time Frame: at day 2
at day 2
Variation of RV systolic function from baseline in patients without MACE
Time Frame: at day 2
at day 2
Variation of RV systolic function from baseline in patients with MACE
Time Frame: at day 15
at day 15
Variation of RV systolic function from baseline in patients without MACE
Time Frame: at day 15
at day 15
Variation of RV systolic function from baseline in patients with MACE
Time Frame: within day 30
within day 30
Variation of RV systolic function from baseline in patients without MACE
Time Frame: within day 30
within day 30
Assessment of RV systolic function preoperatively
Time Frame: at day 30
at day 30
occurrence of a postoperative complication
Time Frame: at day 30
at day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 15, 2021

Primary Completion (ANTICIPATED)

September 1, 2024

Study Completion (ANTICIPATED)

September 1, 2024

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

September 24, 2021

First Posted (ACTUAL)

September 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2021_843_0030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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