EducationWeb-SimTEENCT03262532
Assessment of a Web-Based Simulation in Transesophageal Echocardiography (TEE) Views
An observational study of Education and Training, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Web-base simulator and No web-base simulator
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 13 Mar 2017to 1 Sep 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- Residents or fellows in anesthesia, cardiology and critical care enrolled at the Toronto General Hospital
Who cannot join
- Residents or fellows in anesthesia, cardiology and critical care with prior experience with TEE probe manipulation
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
Official title: 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.
Read more
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.
- Being tested
- Web-base simulator, No web-base simulator
- Keywords
- Interactive web-base simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-base simulatorOther
Training manipulation of TEE using a Web-based simulator
No web-base simulatorOther
Training manipulation of TEE with out a web-base simulator
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Learning TEE manipulation with a Web-based TEE simulation module Receives: Other: Web-base simulator | |
| Control | Learning a TEE manipulation without the Web-based TEE simulation Receives: Other: No web-base simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEE simulation model decreases time to select image acquisition in trainee participant vs. participants trained by reading material only
The metrics for acquiring each image will be recorded by the model, the primary measurement will be time in seconds per view acquired.
Measured: 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 outcomes (1)
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
Each image will be captured by the model and graded according to a 5 point scale.
Measured: 2 week review 1 session for assessment- time required to acquire 10 views
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start13 Mar 2017
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EducationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262532
- Sponsor's protocol ID
- REB 15-9547
- Acronym
- Web-SimTEE
- Status last verified
- Nov 2017
- First submitted
- 30 Mar 2017
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Publication
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Web-Based Simulation Module to Improve Performance in Obtaining Standard Transesophageal Echocardiography (TEE) Views
- ClinicalTrials.gov ID
- NCT03262532
- Acronym / sponsor ID
- Web-SimTEE / REB 15-9547
- Keywords
- Interactive web-base simulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 25 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: Web-base simulatorLearning TEE manipulation with a Web-based TEE simulation module |
| Control | – | Other: No web-base simulatorLearning a TEE manipulation without the Web-based TEE simulation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Residents or fellows in anesthesia, cardiology and critical care enrolled at the Toronto General Hospital
Key exclusion criteria (1 listed)
- Residents or fellows in anesthesia, cardiology and critical care with prior experience with TEE probe manipulation
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 |
|---|---|---|
| Web-base simulatorTraining manipulation of TEE using a Web-based simulator | Other | Experimental |
| No web-base simulatorTraining manipulation of TEE with out a web-base simulator | Other | Control |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- Individual participant dataSharing planned: Yes. Publication
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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 Education and Training, run by University Health Network, Toronto 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 1 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: status not confirmed, as of the sponsor's last update on 20 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annette Vegas, MD (416-340-4800 ext. 5543, annette.vegas@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 20 Feb 2018.