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

March 18, 2024 updated by: Centre Hospitalier Universitaire de Nīmes

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes Cedex 9, France, 30029
        • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Procedure: echocardiography
Four measurements in echocardiography performed in addition to standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluate the interobserver reproducibility
Time Frame: Day 0
evaluate the interobserver reproducibility of the automatic measurement of LVEF with a pocket ultrasound device
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the interobserver reproducibility of visual LVEF
Time Frame: day 0
Assess the interobserver reproducibility of visual LVEF
day 0
Interobserver reproducibility of the visual LVEF measurement;
Time Frame: Day 0
Assess the interobserver reproducibility of the visual LVEF measurement;
Day 0
Evaluate the intraobserver reproducibility of the automatic LVEF measurement
Time Frame: 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.
Time Frame: Day 0
Compare the feasibility of each method (visual and automatic) to obtain 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
Time Frame: Day 0
Evaluation of Image quality obtained by each méthod (Visual and Automatic)
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Xavier Bobbia, MD, Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2020

Primary Completion (Actual)

October 27, 2022

Study Completion (Actual)

October 27, 2022

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOCAL/2019/XB-01
  • 2019-A03140-57 (Other Identifier: RCB number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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