Evaluation of LVEF by a New Automatic Evaluation Tool in a Pocket Ultrasound Scanner

Not Applicable

Completed

• Conditions: Echocardiography; Technology Assessment, Biomedical; Heart Diseases; Medicine, Emergency
• Interventions: Procedure: echocardiography

• Registration Number: NCT04366453
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

Clinical ultrasound has become essential in emergency medicine. The guidelines are to use of echocardiography in specific contexts: dyspnea, hypotension or chest pain. The evaluation of left ventricle ejection fraction (LVEF) is one of the basic objectives of echocardiography. The reference assessment in emergency medicine is visual assessment. It suffers from poor inter-observer reproducibility. Pocket ultrasound scanners seem to meet the constraints of point-of-care ultrasound. A new tool is available on a pocket ultrasound device: the automatic evaluation of LVEF. Its interest could be to have a better inter-observer reproducibility than visual evaluation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-24
• Study First Posted: 2020-04-29
• Study Start: 2020-11-18
• Primary Completion: 2022-10-27
• Study Completion: 2022-10-27
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Echocardiography	echocardiography	• Echocardiography performed by the evaluator 1: 2 LVEF visual evaluations 2 LVEF automatic evaluations • Echocardiography performed by the evaluator 2: 2 LVEF visual evaluations 2 LVEF automatic evaluations

Primary Outcome Measures

Name	Time	Method
evaluate the interobserver reproducibility	Day 0	evaluate the interobserver reproducibility of the automatic measurement of LVEF with a pocket ultrasound device

Secondary Outcome Measures

Name	Time	Method
Evaluate the intraobserver reproducibility of the automatic LVEF measurement	Day 0	Evaluate the intraobserver reproducibility of the automatic LVEF measurement
Interobserver reproducibility of the visual LVEF measurement;	Day 0	Assess the interobserver reproducibility of the visual LVEF measurement;
Assess the interobserver reproducibility of visual LVEF	day 0	Assess the interobserver reproducibility of visual LVEF
Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination.	Day 0	Compare the feasibility of each method (visual and automatic) to obtain an ultrasound image useable by the doctor performing the examination.
Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination considering image quality	Day 0	Evaluation of Image quality obtained by each méthod (Visual and Automatic)

Trial Locations

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France