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Effectiveness of Simulation-based Training on Transoesophageal Echocardiography Learning

NCT05564507 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2022-10-03

No results posted yet for this study

Summary

Background:

Simulation-based training in transesophageal echocardiography (TEE) seems promising. However, data are limited to non-randomized or single-center studies.

Objectives:

This large multicenter randomized, parallel-group, unblinded, study will assess the impact of simulation-based versus traditional teaching on TEE knowledge and performance for medical fellows in cardiology.

Eligibility:

* All consecutive fellows in cardiology of all training levels (year 1-4)
* who have never performed a TEE alone

Design:

* Multicenter, parallel-group, unblinded, randomized study with a prospective enrollment of all consecutive fellows in cardiology of all training level (year 1 to 4) who were recruited in 42 centers throughout France.
* Randomization with stratification by center will be performed at the individual (fellow) level in 1:1 ratio to assign all the fellows to the traditional group or to the TEE simulation-based training group.
* Each participant will complete two different tests during the study: 1) a pre-training test before starting the educational program; and 2) a final test performed 3 months after the end of the educational program. Each of these tests will include a theoretical test and a practical test on a TEE simulator.
* The coprimary outcomes of the study to compare the two groups will be the scores in the final theoretical and practical tests after the training will be completed.

Conditions

Interventions

DIAGNOSTIC_TEST

TEE simulation-based training

All participants of the TEE simulation-based training group received: 1. a traditional didactic training using e-learning with a national free-access online course; 2. two teaching sessions using a TEE simulator for 2 hours per session. The simulation session will involve standardized initial teaching of normal cardiac, including anatomy of mitral valve with some mitral regurgitation cases, aortic valve, tricuspid valve, interatrial septum, and left atrial appendage, and demonstration of image acquisition by the teacher (time duration: 30 min). The duration of each session was 2 h with a 6:1 student to instructor ratio. Each subject had a dedicated 20 min of hands-on to manipulate the probe and undertake a sequential TEE examination under the supervision of the teacher. Other participants could watch their colleagues working on the TEE simulator.

Sponsors & Collaborators

  • Groupe des jeunes de la filiale d'imagerie cardiovasculaire

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-02-01
Completion
2022-02-01

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05564507 on ClinicalTrials.gov