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RVLSBO: Interchangeability of Right Ventricle Longitudinal Shortening in Echocardiography

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT05404737
Collaborator
(none)
90
Enrollment
1
Location
11
Anticipated Duration (Months)
8.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: transthoracic echocardiography (TTE)
  • Other: transoesophageal echocardiography (TEE).
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Interchangeability of Right Ventricle Longitudinal Shortening Fraction Measurements Performed by Trans-thoracic and Trans-esophageal Echocardiography in the Operating Room
Actual Study Start Date :
May 31, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Variation of the RV-LSF (in %) between TTE and TEE [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Picardie Amiens France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT05404737
Other Study ID Numbers:
  • PI2021_843_0056
First Posted:
Jun 3, 2022
Last Update Posted:
Jun 3, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens
Right ventricle
speckle tracking
Strains
cardiac surgery
Additional relevant MeSH terms:
Sprains and Strains

Study Results

No Results Posted as of Jun 3, 2022