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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Ejection Fraction of the Left Ventricle in the Emergency Room by a New Automatic Evaluation Tool in a Pocket Ultrasound Scanner: A Reproducibility Study

Conditions
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Echocardiography, Medicine, Emergency, Technology Assessment, Biomedical, Heart Diseases

Intervention / Treatment
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* Procedure: echocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patient over 18 years of age Management in the investigator centre Admitted for dyspnea or hypotension or chest pain Exclusion criteria: Age < 18 years Patient not benefiting from a social security system Patient deprived of liberty Patient under the protection of justice, under guardianship or curatorship Patient refusing to participate in the study Inability to provide the patient with informed information

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Echocardiography<br>• 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 | Procedure: echocardiography<br>* Four measurements in echocardiography performed in addition to standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the interobserver reproducibility | evaluate the interobserver reproducibility of the automatic measurement of LVEF with a pocket ultrasound device | Day 0 | 

Secondary Outcome Measures

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