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

NCT ID: NCT04366453

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-18

Study Completion Date

2022-10-27

Brief Summary

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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.

Detailed Description

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Conditions

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Echocardiography Medicine, Emergency Technology Assessment, Biomedical Heart Diseases

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

echocardiography

Intervention Type PROCEDURE

Four measurements in echocardiography performed in addition to standard care

Interventions

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echocardiography

Four measurements in echocardiography performed in addition to standard care

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier Bobbia, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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2019-A03140-57

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2019/XB-01

Identifier Type: -

Identifier Source: org_study_id

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