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

Heart Diseases Clinical Trial

— ReproAuto_FEVG  

Official title:

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 Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366453
• Other study ID #: LOCAL/2019/XB-01
• Secondary ID: 2019-A03140-57
• Status: Completed
• Phase: N/A
• Start date: November 18, 2020
• Est. completion date: October 27, 2022

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 27, 2022
• Est. primary completion date: October 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Echocardiography
• Emergencies
• Heart Diseases
• Medicine, Emergency
• Technology Assessment, Biomedical

Intervention

Procedure:
• echocardiography
Four measurements in echocardiography performed in addition to standard care

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate the interobserver reproducibility	evaluate the interobserver reproducibility of the automatic measurement of LVEF with a pocket ultrasound device	Day 0
Secondary	Assess the interobserver reproducibility of visual LVEF	Assess the interobserver reproducibility of visual LVEF	day 0
Secondary	Interobserver reproducibility of the visual LVEF measurement;	Assess the interobserver reproducibility of the visual LVEF measurement;	Day 0
Secondary	Evaluate the intraobserver reproducibility of the automatic LVEF measurement	Evaluate the intraobserver reproducibility of the automatic LVEF measurement	Day 0
Secondary	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
Secondary	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