Assessment of a Web-Based Simulation in Transesophageal Echocardiography (TEE) Views (Web-SimTEE)

February 16, 2018 updated by: University Health Network, Toronto

Assessment of a Web-Based Simulation Module to Improve Performance in Obtaining Standard Transesophageal Echocardiography (TEE) Views

Transesophageal echocardiography (TEE) is often used by anesthesiologists during cardiac surgery, as a monitoring tool in non-cardiac surgery, and as a point of care diagnostic tool in the intensive care unit (ICU). Furthermore, TEE is becoming a core skill in many specialties to facilitate focused cardiovascular assessment in hemodynamically compromised patients in various settings. Educators must determine how to best instruct current and future trainees to achieve clinical competence in TEE within a time limited and constantly expanding medical curriculum.

In this study the investigators will evaluate a new online TEE Simulation module as a learning tool to accelerate and enhance traditional clinical teaching. This project will evaluate a new online TEE Simulation module that replicates the actions required to adjust TEE probe position and the ultrasound plane in relation to a 3D heart model.

The investigators hypothesize that experience with the online TEE simulation module will improve the ability of trainees to independently perform TEE probe manipulations necessary to obtain standard TEE views. The proposed study will answer this question by measuring the performance of trainees in obtaining 10 of the 25 standard TEE views using the Vimedix mannequin-based ultrasonography simulator following an hour of review of the online TEE Simulation module.

The educational benefit of the Web-based TEE simulation module, will be evaluated by 20 novices randomly assigned to two groups, a control group of 10 subjects without exposure to the Web-based simulation, and an experimental group of 10 subjects with exposure to the Web-based simulation. Both groups will be assessed on their performance in attaining the 10 standard TEE views with the Vimedix simulator.

Study Overview

Status

Status

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

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.

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.
Observational

Enrollment (Anticipated)

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.
20

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • Toronto General Hospital

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We will recruit residents and fellows during their training from the University of Toronto postgraduate programs in anesthesia, cardiology and critical care. They will have some knowledge of transthoracic echocardiography but no prior experience with TEE probe manipulation

Description

Inclusion Criteria:

  • Residents or fellows in anesthesia, cardiology and critical care enrolled at the Toronto General Hospital

Exclusion Criteria:

  • Residents or fellows in anesthesia, cardiology and critical care with prior experience with TEE probe manipulation

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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
Learning TEE manipulation with a Web-based TEE simulation module
Other: Web-base simulator
Training manipulation of TEE using a Web-based simulator
Control
Learning a TEE manipulation without the Web-based TEE simulation
Other: No web-base simulator
Training manipulation of TEE with out a web-base simulator

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
TEE simulation model decreases time to select image acquisition in trainee participant vs. participants trained by reading material only
Time Frame: 2 week review 1 session for assessment (Control: time required to acquire 10 views, Intervention: I hour session with online simulator plus time required to acquire 10 views)
The metrics for acquiring each image will be recorded by the model, the primary measurement will be time in seconds per view acquired.
2 week review 1 session for assessment (Control: time required to acquire 10 views, Intervention: I hour session with online simulator plus time required to acquire 10 views)

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
TEE simulation model improves select image quality in trainee participants vs. participants trained by reading material only as assessed by a expert review panel of echo cardiographers
Time Frame: 2 week review 1 session for assessment- time required to acquire 10 views
Each image will be captured by the model and graded according to a 5 point scale.
2 week review 1 session for assessment- time required to acquire 10 views

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.
University Health Network, Toronto

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.
March 13, 2017

Primary Completion (Anticipated)

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.
July 1, 2018

Study Completion (Anticipated)

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.
September 1, 2018

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).
March 30, 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 23, 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 25, 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.
February 20, 2018

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.
February 16, 2018

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.
November 1, 2017

More Information

Terms related to this study

Keywords

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.
  • REB 15-9547

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Publication

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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