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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Echocardiography; Medicine, Emergency; Technology Assessment, Biomedical
• Intervention / Treatment: Procedure: echocardiography

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 9, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Procedure: echocardiography; Four measurements in echocardiography performed in addition to standard care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Xavier Bobbia, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2020
• Primary Completion (Actual): October 27, 2022
• Study Completion (Actual): October 27, 2022

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Disease Attributes; Heart Diseases; Emergencies
• Other Study ID Numbers: LOCAL/2019/XB-01; 2019-A03140-57 (Other Identifier: RCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No