Cardiac DiseaseTEENCT06164171
Transesophageal Echocardiography (TEE) and Simulation : a Preferred Learning Path
An observational study of Cardiac Disease, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Transesophageal echocardiography (TEE) has gradually become the technique of choice for continuous functional examination of the heart despite the significant training required for its interpretation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2020to 31 Dec 2023
- 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 years and older
- All sexes
- Adult, Older adult
Study population: 1st or 2nd year DESAR interns who participated in the continuing education program
Who may be able to join
- 1st or 2nd year DESAR interns who participated in the continuing education program
- Interns who agreed to participate in the professional practice evaluation study
Who cannot join
- Interns who did not participate in the training
- Residents who do not agree to take the final test
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Réanimation Chirurgicale - CHU de Strasbourg - France
Strasbourg, 67091
Walid OULEHRI, MD, 33 3 69 55 12 71, walid.oulehri@chru-strasbourg.fr
Walid OULEHRI, MD
About this study
Transesophageal echocardiography (TEE) has gradually become the technique of choice for continuous functional examination of the heart despite the significant training required for its interpretation. It has proven to be the safest, fastest, and most reliable technique for diagnosing most intra- and postoperative hemodynamic problems. Indeed, the transesophageal route is particularly well adapted to the situation of intubated patients, whether in the operating room, in the outpatient department or in intensive care. It offers images that are easier to obtain and of better quality than the transthoracic route; it can be performed without interfering with surgical activity or resuscitation. However, TEE training is often poor during the DES training in anesthesia and resuscitation, reserved for the few interns who will learn in a specific department where TEE is used on a daily basis.
Thus, simulation is a logical and recognized means by which technical aspects, mechanisms involved in the understanding of a situation, reasoning and decision making can be analyzed and improved.
Read more
The RFE SFAR 2019 recommendations suggest the use of simulation for the learning of technical gestures in initial training in order to improve their acquisition.
This study is therefore part of a technical and diagnostic improvement of a practice, which appears to be essential in several fields in anesthesia and intensive care, for a technique still not sufficiently acquired by many future practitioners.
- Conditions
- Cardiac Disease
- Keywords
- Cardiac disease, Transesophageal echocardiography, TEE, High definition simulator
- Medical subject headings
- Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of a population of medical students to perform a TEE thanks to the contribution of simulation to their learning compared to a population of interns not trained on a high definition simulator Time in seconds required to make the 11 cuts
Measured: 1 hour after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start9 Jun 2020
- Primary completionDec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164171
- Sponsor's protocol ID
- 7646
- Acronym
- TEE
- Status last verified
- Dec 2023
- First submitted
- 8 Nov 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transesophageal Echocardiography (TEE) and Simulation : a Preferred Learning Path
- ClinicalTrials.gov ID
- NCT06164171
- Acronym / sponsor ID
- TEE / 7646
- Conditions
- Cardiac Disease
- Keywords
- Cardiac disease, Transesophageal echocardiography, TEE, High definition simulator
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Dec 2023 (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.
Transesophageal echocardiography (TEE) has gradually become the technique of choice for continuous functional examination of the heart despite the significant training required for its interpretation. It has proven to be the safest, fastest, and most reliable technique for diagnosing most intra- and postoperative hemodynamic problems. Indeed, the transesophageal route is particularly well adapted to the situation of intubated patients, whether in the operating room, in the outpatient department or in intensive care. It offers images that are easier to obtain and of better quality than the transthoracic route; it can be performed without interfering with surgical activity or resuscitation. However, TEE training is often poor during the DES training in anesthesia and resuscitation, reserved for the few interns who will learn in a specific department where TEE is used on a daily basis.
Thus, simulation is a logical and recognized means by which technical aspects, mechanisms involved in the understanding of a situation, reasoning and decision making can be analyzed and improved.
The RFE SFAR 2019 recommendations suggest the use of simulation for the learning of technical gestures in initial training in order to improve their acquisition.
This study is therefore part of a technical and diagnostic improvement of a practice, which appears to be essential in several fields in anesthesia and intensive care, for a technique still not sufficiently acquired by many future practitioners.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1st or 2nd year DESAR interns who participated in the continuing education program
Key inclusion criteria (2 listed)
- 1st or 2nd year DESAR interns who participated in the continuing education program
- Interns who agreed to participate in the professional practice evaluation study
Key exclusion criteria (2 listed)
- Interns who did not participate in the training
- Residents who do not agree to take the final test
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
Ability of a population of medical students to perform a TEE thanks to the contribution of simulation to their learning compared to a population of interns not trained on a high definition simulator Time in seconds required to make the 11 cuts
Time frame: 1 hour after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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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.
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 Cardiac Disease, run by University Hospital, Strasbourg, France 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 2 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: status not confirmed, as of the sponsor's last update on 11 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Walid OULEHRI, MD (33 3 69 55 12 71, walid.oulehri@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of a population of medical students to perform a TEE thanks to the contribution of simulation to their learning compared to a population of interns not trained on a high definition simulator Time in seconds required to make the 11 cuts (time frame: 1 hour after operation). 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 11 Dec 2023.