Back to resultsEvaluation of LVEF by a New Automatic Evaluation Tool in a Pocket Ultrasound Scanner (ReproAuto_FEVG)
Primary Purpose
Echocardiography, Medicine, Emergency, Technology Assessment, Biomedical
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
echocardiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Echocardiography
Eligibility Criteria
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
Sites / Locations
- CHRU de Nîmes - Hôpital Universitaire CarémeauRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Echocardiography
Arm Description
• 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
Outcomes
Primary Outcome Measures
evaluate the interobserver reproducibility
evaluate the interobserver reproducibility of the automatic measurement of LVEF with a pocket ultrasound device
Secondary Outcome Measures
Assess the interobserver reproducibility of visual LVEF
Assess the interobserver reproducibility of visual LVEF
Interobserver reproducibility of the visual LVEF measurement;
Assess the interobserver reproducibility of the visual LVEF measurement;
Evaluate the intraobserver reproducibility of the automatic LVEF measurement
Evaluate the intraobserver reproducibility of the automatic LVEF measurement
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.
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)
Full Information
NCT ID
NCT04366453
First Posted
April 22, 2020
Last Updated
November 27, 2020
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT04366453
Brief Title
Evaluation of LVEF by a New Automatic Evaluation Tool in a Pocket Ultrasound Scanner
Acronym
ReproAuto_FEVG
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Echocardiography, Medicine, Emergency, Technology Assessment, Biomedical, Heart Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Echocardiography
Arm Type
Other
Arm Description
• 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
Intervention Type
Procedure
Intervention Name(s)
echocardiography
Intervention Description
Four measurements in echocardiography performed in addition to standard care
Primary Outcome Measure Information:
Title
evaluate the interobserver reproducibility
Description
evaluate the interobserver reproducibility of the automatic measurement of LVEF with a pocket ultrasound device
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Assess the interobserver reproducibility of visual LVEF
Description
Assess the interobserver reproducibility of visual LVEF
Time Frame
day 0
Title
Interobserver reproducibility of the visual LVEF measurement;
Description
Assess the interobserver reproducibility of the visual LVEF measurement;
Time Frame
Day 0
Title
Evaluate the intraobserver reproducibility of the automatic LVEF measurement
Description
Evaluate the intraobserver reproducibility of the automatic LVEF measurement
Time Frame
Day 0
Title
Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination.
Description
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
Title
Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination considering image quality
Description
Evaluation of Image quality obtained by each méthod (Visual and Automatic)
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier Bobbia, MD
Phone
+33.(0)4.66.68.30.50
Email
xavier.bobbia@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Bobbia, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 9
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Bobbia, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of LVEF by a New Automatic Evaluation Tool in a Pocket Ultrasound Scanner
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