EchocardiographyReproAuto_FEVGNCT04366453
Evaluation of LVEF by a New Automatic Evaluation Tool in a Pocket Ultrasound Scanner
A study testing echocardiography in people with Echocardiography and Medicine, Emergency, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Echocardiography, Medicine, Emergency, Technology Assessment, Biomedical
- What is being tested?
- echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2020to 27 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years of age
- Management in the investigator centre
- Admitted for dyspnea or hypotension or chest pain
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- echocardiography
- Medical subject headings
- Emergencies, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyProcedure or surgery
Four measurements in echocardiography performed in addition to standard care
| Study group | Role | What they receive |
|---|---|---|
| Echocardiography | Other | • 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 Receives: Procedure: echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the interobserver reproducibility
evaluate the interobserver reproducibility of the automatic measurement of LVEF with a pocket ultrasound device
Measured: Day 0
Secondary outcomes (5)
Assess the interobserver reproducibility of visual LVEF
Assess the interobserver reproducibility of visual LVEF
Measured: day 0
Interobserver reproducibility of the visual LVEF measurement;
Assess the interobserver reproducibility of the visual LVEF measurement;
Measured: Day 0
Evaluate the intraobserver reproducibility of the automatic LVEF measurement
Evaluate the intraobserver reproducibility of the automatic LVEF measurement
Measured: Day 0
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.
Measured: Day 0
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)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start18 Nov 2020
- Primary completion27 Oct 2022
- Study completion27 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EchocardiographyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Bobbia, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366453
- Sponsor's protocol ID
- LOCAL/2019/XB-01
- Other IDs
- 2019-A03140-57
- Acronym
- ReproAuto_FEVG
- Status last verified
- Mar 2024
- First submitted
- 22 Apr 2020
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04366453
- Acronym / sponsor ID
- ReproAuto_FEVG / LOCAL/2019/XB-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Echocardiography | Other | Procedure: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient over 18 years of age
- Management in the investigator centre
- Admitted for dyspnea or hypotension or chest pain
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echocardiographyFour measurements in echocardiography performed in addition to standard care | Procedure or surgery | Echocardiography |
Primary outcome
evaluate the interobserver reproducibility
Time frame: Day 0
evaluate the interobserver reproducibility of the automatic measurement of LVEF with a pocket ultrasound device
5 secondary outcomes
Assess the interobserver reproducibility of visual LVEF
Time frame: day 0
Interobserver reproducibility of the visual LVEF measurement;
Time frame: Day 0
Evaluate the intraobserver reproducibility of the automatic LVEF measurement
Time frame: Day 0
Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Bobbia, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing echocardiography in people with Echocardiography and Medicine, Emergency, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the interobserver reproducibility (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.