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NCT05404737 Clinical Trial

Interchangeability of Right Ventricle Longitudinal Shortening in Echocardiography

Cardiac Surgery Clinical Trial

— RVLSBO  

Official title:
Interchangeability of Right Ventricle Longitudinal Shortening Fraction Measurements Performed by Trans-thoracic and Trans-esophageal Echocardiography in the Operating Room

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05404737
Other study ID # PI2021_843_0056
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 31, 2022
Est. completion date January 1, 2023

Study information
Verified date January 2023
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

RV longitudinal shortening fraction (RV-SLF) is based on the analysis of the tricuspid annulus displacement (TAD) and can be performed in transthoracic (TTE) or transoesophageal echocardiography (TEE). Having an 2D-STE interchangeable parameter would allow accurate measurement of RV systolic function before, during and after cardiac surgery. However, to date, there are no data on the interchangeability of RV-LSF measurements performed in TTE and TEE. The aim of the study is to evaluate the interchangeability of TTE and TEE measurements of RV-LSF during cardiopulmonary bypass surgery.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date January 1, 2023
Est. primary completion date January 1, 2023
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 cardiac surgery under cardiopulmonary bypass. - Information of the patient and collection of his non-opposition Exclusion Criteria: - Patient with a contraindication to the realization of TEE (gastric or mediastinal pathology) - Patient with poor echogenicity on TEE not allowing evaluation of 2D-STE parameters of the right ventricle - Patient with a rapid supraventricular rhythm disorder (HR > 100) at the time of TTE and/or TEE.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• transthoracic echocardiography (TTE)
In order to evaluate the interchangeability of RV-LSF, a TTE will be performed just after the placement of general anesthesia, when the patient is under mechanical ventilation
• transoesophageal echocardiography (TEE).
During cardiopulmonary bypass surgery patients is monitored by a TEE as recommended.

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 Variation of the RV-LSF (in %) between TTE and TEE RV-LSF is : Right ventricular longitudinal shortening fraction. RV-LSF is an angle-independent and automatically calculated speckle-tracking parameter and reproducible parameter. one day
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