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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04366453
Acronym
ReproAuto_FEVG
Enrollment
120
Registered
2020-04-29
Start date
2020-11-18
Completion date
2022-10-27
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREechocardiography

Four measurements in echocardiography performed in addition to standard care

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
evaluate the interobserver reproducibilityDay 0evaluate the interobserver reproducibility of the automatic measurement of LVEF with a pocket ultrasound device

Secondary

MeasureTime frameDescription
Assess the interobserver reproducibility of visual LVEFday 0Assess the interobserver reproducibility of visual LVEF
Interobserver reproducibility of the visual LVEF measurement;Day 0Assess the interobserver reproducibility of the visual LVEF measurement;
Evaluate the intraobserver reproducibility of the automatic LVEF measurementDay 0Evaluate the intraobserver reproducibility of the automatic LVEF measurement
Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination.Day 0Compare 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 qualityDay 0Evaluation of Image quality obtained by each méthod (Visual and Automatic)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026