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OpenTrials
Completed

NCT Number: NCT04366453

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

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.

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Key information

Conditions

Echocardiography Cardiovascular Diseases Disease Attributes Emergencies Heart Diseases Medicine, Emergency Pathologic Processes Pathological Conditions, Signs and Symptoms Technology Assessment, Biomedical

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiography

Procedure

Four measurements in echocardiography performed in addition to standard care

Primary outcomes

  1. evaluate the interobserver reproducibility

    Time frame: Day 0

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

Secondary outcomes

  1. Assess the interobserver reproducibility of visual LVEF

    Time frame: day 0

    Assess the interobserver reproducibility of visual LVEF

  2. Interobserver reproducibility of the visual LVEF measurement;

    Time frame: Day 0

    Assess the interobserver reproducibility of the visual LVEF measurement;

  3. Evaluate the intraobserver reproducibility of the automatic LVEF measurement

    Time frame: Day 0

    Evaluate the intraobserver reproducibility of the automatic LVEF measurement

  4. 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.

  5. 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: ReproAuto_FEVG

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2020
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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