Ventricular FailureNCT04978389
Inter-observer Reproductibility of Visual Estimation of Left Ventricular Ejection Fraction in Critical Care
An observational study of Ventricular Failure, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Inter-observer reproductibility of visual estimation of left ventricular ejection fraction is known to be good in cardiology but has not been studied in ICU. The goal of the study is to determine if this reproductibility is good enough. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Failure
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 20 Dec 2021
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: practitioners working in intensive care.
Who may be able to join
- practitioners working in intensive care.
- age > 18 years
Who cannot join
- Age under 18
Trial locations and contacts
1 site in 1 country.
About this study
Inter-observer reproductibility of visual estimation of left ventricular ejection fraction is known to be good in cardiology but has not been studied in ICU. The goal of the study is to determine if this reproductibility is good enough.
- Conditions
- Ventricular Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
reproductibility of LVEF in percentage
reproductibility of LVEF in percentage
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Sep 2021
- Primary completion1 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kada KLOUCHE, MD PhD, Study director, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978389
- Sponsor's protocol ID
- RECHMPL21_0462
- Status last verified
- Jan 2022
- First submitted
- 19 Jul 2021
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-observer Reproductibility of Visual Estimation of Left Ventricular Ejection Fraction in Critical Care
- ClinicalTrials.gov ID
- NCT04978389
- Acronym / sponsor ID
- RECHMPL21_0462
- Conditions
- Ventricular Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 27 Jul 2021 (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.
Inter-observer reproductibility of visual estimation of left ventricular ejection fraction is known to be good in cardiology but has not been studied in ICU. The goal of the study is to determine if this reproductibility is good enough.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- practitioners working in intensive care.
Key inclusion criteria (2 listed)
- practitioners working in intensive care.
- age > 18 years
Key exclusion criteria (1 listed)
- Age under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
reproductibility of LVEF in percentage
Time frame: day 1
reproductibility of LVEF in percentage
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 2 Feb 2022.
- Individual participant dataSharing planned: Undecided. NC
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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.
Kada KLOUCHE, MD PhD study director
UH Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Failure, run by University Hospital, Montpellier 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 2 inclusion and 1 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 2 Feb 2022. 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?
reproductibility of LVEF in percentage (time frame: day 1). 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 2 Feb 2022.