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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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