- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05404737
Interchangeability of Right Ventricle Longitudinal Shortening in Echocardiography (RVLSBO)
Interchangeability of Right Ventricle Longitudinal Shortening Fraction Measurements Performed by Trans-thoracic and Trans-esophageal Echocardiography in the Operating Room
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Amiens, France
- CHU Amiens Picardie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Variation of the RV-LSF (in %) between TTE and TEE
Time Frame: one day
|
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
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2021_843_0056
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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