Implementation and Evaluation of a Perceptual Learning Module on Visual Estimation of LVEF

July 2, 2025 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

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:

  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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. selection and validation of TEE cases,
  2. development of two versions of a test and of the PLM,
  3. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H2X 3E4
        • Centre hospitalier de l'Université de Montréal (CHUM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pre, post, delayed test
Participants will not do the PLM, but will perform a pretest, a posttest and a delayed test at 6 months
Other: Pre, post, delayed test
Participants will perform a pretest, a posttest and a delayed test at 6 months.
Experimental: PLM group (pre, post, delayed test, PLM)
Participants will do a pretest, the PLM, a posttest and a delayed test at 6 months
Other: Pre, post, delayed test
Participants will perform a pretest, a posttest and a delayed test at 6 months.
Other: PLM
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At baseline (pretest) and on the immediate posttest

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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
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
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
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.
During the PLM, at the end of the first on-line session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Université de Montréal

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Arnaud Robitaille, MD, FRCPC, Centre hospitalier de l'Université de Montréal (CHUM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 6, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 5, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17.119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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