Medical EducationNCT03245567
Implementation and Evaluation of a Perceptual Learning Module on Visual Estimation of LVEF
A study testing PLM and Pre, post, delayed test in people with Medical Education, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
This study is designed to: 1. Implement a Web platform intended to host perceptual learning modules (PLMs) 2. Implement and assess a PLM designed to improve the capacity of first-year residents and fourth-year medical students to visually estimate the left ventricular ejection fraction (LVEF) with transesophageal… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medical Education
- What is being tested?
- PLM and Pre, post, delayed test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jul 2018to 1 May 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Residents in their first year of training or fourth-year medical students having access to a computer with a high speed internet connection
- Residents or medical students with no significant experience in echocardiography
Who cannot join
- Smartphones and tablets will not be acceptable to perform the tests due to their smaller screens
- Residents or medical students having significant experience with transthoracic or transesophageal echocardiography
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
About this study
Official title: Implementation and Evaluation of a Perceptual Learning Module on the Visual Estimation of Left Ventricular Ejection Fraction Using Transesophageal Echocardiography
This study is designed to:
- Implement a Web platform intended to host perceptual learning modules (PLMs)
- Implement and assess a PLM designed to improve the capacity of first-year residents and fourth-year medical students to visually estimate the left ventricular ejection fraction (LVEF) with transesophageal echocardiography (TEE) images.
The hypothesis of the study is that the PLM will improve the visual assessment of LVEF by TEE in junior residents and medical students.
Read the detailed description
TEE is increasingly used for perioperative diagnosis and monitoring. However, learning TEE may be long and difficult: guidelines suggest that learners perform and interpret hundreds of TEE exams during their training. Even if this learning process has been used successfully for many years, it has important limitations, especially in the context of an ever-increasing number of trainees: access to patients and TEE experts is limited, and the extensive period of time required to train is also a problem.
Simulators have gained popularity as tools for teaching echocardiography, showing benefits mostly regarding probe handling and image acquisition. Some simulators may also be useful to replicate some diseases, but most simulators can only replicate a limited variety of diseases, and mostly typical presentations. This is an important limitation when it comes to teaching image interpretation. In order to develop their expertise, trainees have to be exposed to a wide range of normal variations and to more subtle abnormalities.
PLMs represent an alternative modality to teach image interpretation, and are already used in other fields. PLMs are online tools created to enhance the development of pattern recognition, a skill required to efficiently interpret TEE images. With PLMs, learners observe a series of images or videoclips and must answer a question about each image in a short period of time. Each answer is followed by an immediate feedback (the correct answer). By observing a large number of images online and by receiving systematic and expert feedback, the trainee quickly learns to extract efficiently the required information from the image.
This study will aim to evaluate the effects of a PLM on the ability of junior residents and medical students to correctly estimate visually the left ventricular ejection faction using TEE images.
Methods:
A team of experienced programmers will develop a Web platform, which will allow the identification of both participants and TEE experts, manage the consent process, host the tests used to assess the participants' expertise and the PLM itself, as well as manage the TEE images and the study data.
The pilot study designed to assess the impact of the PLM on the visual estimation of LVEF will be composed of the following steps:
- selection and validation of TEE cases,
- development of two versions of a test and of the PLM,
- analysis of the impact of the PLM on participants' performance vs a control group.
Each TEE case used in this study will comprise 3 short video loops containing the following standardised echocardiographic views:
- midesophageal four chamber view
- midesophageal two chamber view
- midesophageal long axis view
Prior to inclusion in the study, each case will be anonymized and then validated by two cardiologists expert in TEE interpretation. Only cases where the visual estimation of the LVEF provided independently by the two TEE experts will differ by no more than 10% will be used. Two different sets of validated images will then be created.
The first set will be comprised of two groups of 20 validated cases (total of 40 cases). These cases will be used to create two versions of a test used to assess participants' expertise in the visual estimation of LVEF at different stages in the research protocol. These cases will not be part of the PLM.
The second set will be comprised of 96 validated cases destined to the PLM. The PLM is designed not to assess the participants' expertise, but to develop their ability to estimate LVEF.
When taking a test on the platform, participants will see the three short video loops of each case simultaneously on the screen for a maximum of 20 seconds, and will then have to provide an estimation of the LVEF. Each answer will be followed immediately by another case, and no feedback will be provided.
When doing the PLM, participants will see the three short video loops of each case simultaneously on the screen for a maximum of 20 seconds, and will then have to provide an estimation of the LVEF. However, each answer will be followed by feedback in the form of the average value of the experts' visual estimates of LVEF. This sequence of "case visualisation - participant estimation - expert feedback" will be repeated 96 times during this PLM.
Residents and medical students will be randomised by the platform to a Control Group and a PLM group. Both groups will participate in two on-line sessions. During the first session, demographic and clinical experience data will be collected. All participants will also perform a pretest to measure their baseline ability to estimate LVEF. Then only the participants randomised to the PLM group will do the PLM. All participants will do a posttest at the end of the first session. Six months later, all participants will return for a second session to perform the delayed test.
At the end of the study, participants of the Control group will be allowed to complete the PLM if they wish to.
- Conditions
- Medical Education
- Being tested
- PLM, Pre, post, delayed test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLMOther
Participants will take the PLM on the visual estimation of LVEF. They will also take a pretest, a post-test and a delayed test at 6 months.
Pre, post, delayed testOther
Participants will perform a pretest, a posttest and a delayed test at 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Pre, post, delayed test | Experimental | Participants will not do the PLM, but will perform a pretest, a posttest and a delayed test at 6 months Receives: Other: Pre, post, delayed test |
| PLM group (pre, post, delayed test, PLM) | Experimental | Participants will do a pretest, the PLM, a posttest and a delayed test at 6 months Receives: Other: PLM; Other: Pre, post, delayed test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in accuracy of LVEF estimation in the Control group versus the PLM group
For each case, the absolute difference between the participant and the experts' estimation of LVEF is calculated. Participant's accuracy is defined as the average of absolute differences for all cases in the test
Measured: At baseline (pretest) and on the immediate posttest
Secondary outcomes (3)
Change in accuracy of LVEF estimation in the Control group versus the PLM group
For each case, the absolute difference between the participant and the experts' estimation of LVEF is calculated. Participant's accuracy is defined as the average of absolute differences for all cases in the test
Measured: At baseline (pretest) and on the delayed post-test (6 months)
Change in the mean response time in seconds to the different tests in the Control group versus the PLM group
Measured: At baseline (pretest), on an immediate posttest, and on the delayed test at 6 months
The evolution of the participants' accuracy in LVEF estimation during the PLM
For each case, the absolute difference between the participant and the experts' estimation of LVEF is calculated. The 96 cases in the PLM will be placed in 8 groups of 12 cases. Participant's accuracy for a group is defined as the average of absolute differences for all cases in that group.
Measured: During the PLM, at the end of the first on-line session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start6 Jul 2018
- Primary completion5 Nov 2018
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medical EducationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, open-label study
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal
- Responsible party
- Sponsor
- Investigators
- Arnaud Robitaille, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245567
- Sponsor's protocol ID
- 17.119
- Status last verified
- Jul 2025
- First submitted
- 7 Aug 2017
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Champagne P, Girard F, Cyr V, Romanelli G, Ruel M, Todorov A, Robitaille A. The impact of a perceptual learning module on novices' ability to visually estimate left ventricular ejection fraction by transesophageal echocardiography: a randomized controlled study. Can J Anaesth. 2021 Oct;68(10):1527-1535. doi: 10.1007/s12630-021-02066-3. Epub 2021 Jul 28.
PubMed 34319575
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of a Perceptual Learning Module on the Visual Estimation of Left Ventricular Ejection Fraction Using Transesophageal Echocardiography
- ClinicalTrials.gov ID
- NCT03245567
- Acronym / sponsor ID
- 17.119
- Conditions
- Medical Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Université de Montréal
- Study start
- 6 Jul 2018 (actual)
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 10 Aug 2017 (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.
This study is designed to:
- Implement a Web platform intended to host perceptual learning modules (PLMs)
- Implement and assess a PLM designed to improve the capacity of first-year residents and fourth-year medical students to visually estimate the left ventricular ejection fraction (LVEF) with transesophageal echocardiography (TEE) images.
The hypothesis of the study is that the PLM will improve the visual assessment of LVEF by TEE in junior residents and medical students.
Detailed description
TEE is increasingly used for perioperative diagnosis and monitoring. However, learning TEE may be long and difficult: guidelines suggest that learners perform and interpret hundreds of TEE exams during their training. Even if this learning process has been used successfully for many years, it has important limitations, especially in the context of an ever-increasing number of trainees: access to patients and TEE experts is limited, and the extensive period of time required to train is also a problem.
Simulators have gained popularity as tools for teaching echocardiography, showing benefits mostly regarding probe handling and image acquisition. Some simulators may also be useful to replicate some diseases, but most simulators can only replicate a limited variety of diseases, and mostly typical presentations. This is an important limitation when it comes to teaching image interpretation. In order to develop their expertise, trainees have to be exposed to a wide range of normal variations and to more subtle abnormalities.
PLMs represent an alternative modality to teach image interpretation, and are already used in other fields. PLMs are online tools created to enhance the development of pattern recognition, a skill required to efficiently interpret TEE images. With PLMs, learners observe a series of images or videoclips and must answer a question about each image in a short period of time. Each answer is followed by an immediate feedback (the correct answer). By observing a large number of images online and by receiving systematic and expert feedback, the trainee quickly learns to extract efficiently the required information from the image.
This study will aim to evaluate the effects of a PLM on the ability of junior residents and medical students to correctly estimate visually the left ventricular ejection faction using TEE images.
Methods:
A team of experienced programmers will develop a Web platform, which will allow the identification of both participants and TEE experts, manage the consent process, host the tests used to assess the participants' expertise and the PLM itself, as well as manage the TEE images and the study data.
The pilot study designed to assess the impact of the PLM on the visual estimation of LVEF will be composed of the following steps:
- selection and validation of TEE cases,
- development of two versions of a test and of the PLM,
- analysis of the impact of the PLM on participants' performance vs a control group.
Each TEE case used in this study will comprise 3 short video loops containing the following standardised echocardiographic views:
- midesophageal four chamber view
- midesophageal two chamber view
- midesophageal long axis view
Prior to inclusion in the study, each case will be anonymized and then validated by two cardiologists expert in TEE interpretation. Only cases where the visual estimation of the LVEF provided independently by the two TEE experts will differ by no more than 10% will be used. Two different sets of validated images will then be created.
The first set will be comprised of two groups of 20 validated cases (total of 40 cases). These cases will be used to create two versions of a test used to assess participants' expertise in the visual estimation of LVEF at different stages in the research protocol. These cases will not be part of the PLM.
The second set will be comprised of 96 validated cases destined to the PLM. The PLM is designed not to assess the participants' expertise, but to develop their ability to estimate LVEF.
When taking a test on the platform, participants will see the three short video loops of each case simultaneously on the screen for a maximum of 20 seconds, and will then have to provide an estimation of the LVEF. Each answer will be followed immediately by another case, and no feedback will be provided.
When doing the PLM, participants will see the three short video loops of each case simultaneously on the screen for a maximum of 20 seconds, and will then have to provide an estimation of the LVEF. However, each answer will be followed by feedback in the form of the average value of the experts' visual estimates of LVEF. This sequence of "case visualisation - participant estimation - expert feedback" will be repeated 96 times during this PLM.
Residents and medical students will be randomised by the platform to a Control Group and a PLM group. Both groups will participate in two on-line sessions. During the first session, demographic and clinical experience data will be collected. All participants will also perform a pretest to measure their baseline ability to estimate LVEF. Then only the participants randomised to the PLM group will do the PLM. All participants will do a posttest at the end of the first session. Six months later, all participants will return for a second session to perform the delayed test.
At the end of the study, participants of the Control group will be allowed to complete the PLM if they wish to.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, open-label study
| Arm | Type | Receives |
|---|---|---|
| Pre, post, delayed test | Experimental | Other: Pre, post, delayed testParticipants will not do the PLM, but will perform a pretest, a posttest and a delayed test at 6 months |
| PLM group (pre, post, delayed test, PLM) | Experimental | Other: PLM, Other: Pre, post, delayed testParticipants will do a pretest, the PLM, a posttest and a delayed test at 6 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Residents in their first year of training or fourth-year medical students having access to a computer with a high speed internet connection
- Residents or medical students with no significant experience in echocardiography
Key exclusion criteria (2 listed)
- Smartphones and tablets will not be acceptable to perform the tests due to their smaller screens
- Residents or medical students having significant experience with transthoracic or transesophageal echocardiography
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 |
|---|---|---|
| PLMParticipants will take the PLM on the visual estimation of LVEF. They will also take a pretest, a post-test and a delayed test at 6 months. | Other | PLM group (pre, post, delayed test, PLM) |
| Pre, post, delayed testParticipants will perform a pretest, a posttest and a delayed test at 6 months. | Other | PLM group (pre, post, delayed test, PLM), Pre, post, delayed test |
Primary outcome
Change in accuracy of LVEF estimation in the Control group versus the PLM group
Time frame: At baseline (pretest) and on the immediate posttest
For each case, the absolute difference between the participant and the experts' estimation of LVEF is calculated. Participant's accuracy is defined as the average of absolute differences for all cases in the test
3 secondary outcomes
Change in accuracy of LVEF estimation in the Control group versus the PLM group
Time frame: At baseline (pretest) and on the delayed post-test (6 months)
Change in the mean response time in seconds to the different tests in the Control group versus the PLM group
Time frame: At baseline (pretest), on an immediate posttest, and on the delayed test at 6 months
The evolution of the participants' accuracy in LVEF estimation during the PLM
Time frame: During the PLM, at the end of the first on-line session
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 4 Jul 2025.
- Derived from this study: PubMed 34319575Champagne P, Girard F, Cyr V, Romanelli G, Ruel M, Todorov A, Robitaille A. The impact of a perceptual learning module on novices' ability to visually estimate left ventricular ejection fraction by transesophageal echocardiography: a randomized controlled study. Can J Anaesth. 2021 Oct;68(10):1527-1535. doi: 10.1007/s12630-021-02066-3. Epub 2021 Jul 28.
- 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.
Arnaud Robitaille, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLM and Pre, post, delayed test in people with Medical Education, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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: finished, as of the sponsor's last update on 4 Jul 2025. 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 Canada. 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?
Change in accuracy of LVEF estimation in the Control group versus the PLM group (time frame: At baseline (pretest) and on the immediate posttest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03245567, which also lists 1 linked publication.
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 4 Jul 2025.