Interchangeability of Right Ventricle Longitudinal Shortening in Echocardiography (RVLSBO)
Primary Purpose
Right Ventricle, Speckle Tracking, Strains
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transthoracic echocardiography (TTE)
transoesophageal echocardiography (TEE).
Sponsored by
About this trial
This is an interventional other trial for Right Ventricle focused on measuring Right ventricle, speckle tracking, Strains, cardiac surgery
Eligibility Criteria
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.
Sites / Locations
- CHU Amiens Picardie
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05404737
First Posted
May 31, 2022
Last Updated
January 17, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05404737
Brief Title
Interchangeability of Right Ventricle Longitudinal Shortening in Echocardiography
Acronym
RVLSBO
Official Title
Interchangeability of Right Ventricle Longitudinal Shortening Fraction Measurements Performed by Trans-thoracic and Trans-esophageal Echocardiography in the Operating Room
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
January 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Ventricle, Speckle Tracking, Strains, Cardiac Surgery
Keywords
Right ventricle, speckle tracking, Strains, cardiac surgery
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
transthoracic echocardiography (TTE)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
transoesophageal echocardiography (TEE).
Intervention Description
During cardiopulmonary bypass surgery patients is monitored by a TEE as recommended.
Primary Outcome Measure Information:
Title
Variation of the RV-LSF (in %) between TTE and TEE
Description
RV-LSF is : Right ventricular longitudinal shortening fraction. RV-LSF is an angle-independent and automatically calculated speckle-tracking parameter and reproducible parameter.
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interchangeability of Right Ventricle Longitudinal Shortening in Echocardiography
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