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

NCT04366453 | Completed

• 2 other identifiers: LOCAL/2019/XB-012019-A03140-57
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• evaluate the interobserver reproducibility

  evaluate the interobserver reproducibility of the automatic measurement of LVEF with a pocket ultrasound device

  Day 0

Secondary Outcomes (5)

• Assess the interobserver reproducibility of visual LVEF

  day 0

• Interobserver reproducibility of the visual LVEF measurement;

  Day 0

• 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.

  Day 0

• Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination considering image quality

  Day 0

Study Arms (1)

Echocardiography

OTHER

• 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

Interventions

echocardiography PROCEDURE

Four measurements in echocardiography performed in addition to standard care

Echocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 18 years of age
• Management in the investigator centre
• Admitted for dyspnea or hypotension or chest pain

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Emergencies; Heart Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases

Study Officials

• Xavier Bobbia, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 29, 2020
• Study Start: November 18, 2020
• Primary Completion: October 27, 2022
• Study Completion: October 27, 2022
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)