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CompletedNCT04366453ReproAuto_FEVGUpdated Mar 19, 2024

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

An interventional study of echocardiography in Echocardiography, Medicine, Emergency and Technology Assessment, Biomedical, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Echocardiography
  • Medicine, Emergency
  • Technology Assessment, Biomedical
  • Heart Diseases
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 120 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • 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

Interventions

  • Procedureechocardiography

    Four measurements in echocardiography performed in addition to standard care

06

What researchers measure

Primary outcomes

  1. evaluate the interobserver reproducibility

    evaluate the interobserver reproducibility of the automatic measurement of LVEF with a pocket ultrasound device

    Time frame: Day 0

Secondary outcomes

  1. Assess the interobserver reproducibility of visual LVEF

    Assess the interobserver reproducibility of visual LVEF

    Time frame: day 0

  2. Interobserver reproducibility of the visual LVEF measurement;

    Assess the interobserver reproducibility of the visual LVEF measurement;

    Time frame: Day 0

  3. Evaluate the intraobserver reproducibility of the automatic LVEF measurement

    Evaluate the intraobserver reproducibility of the automatic LVEF measurement

    Time frame: Day 0

  4. 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.

    Time frame: Day 0

  5. 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)

    Time frame: Day 0

07

Study locations

1 site
  • CHRU de Nîmes - Hôpital Universitaire Carémeau
    Nîmes Cedex 9, 30029, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04366453
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Apr 29, 2020
Start date
Nov 18, 2020
Primary completion
Oct 27, 2022
Completion
Oct 27, 2022
Last update
Mar 19, 2024

Study contacts

Xavier Bobbia, MD
principal investigator · Centre Hospitalier Universitaire de Nîmes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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