Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-05 @ 5:23 PM
Study NCT ID:
NCT03262532
Status:
UNKNOWN
Last Update Posted:
2018-02-20
First Post:
2017-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of a Web-Based Simulation in Transesophageal Echocardiography (TEE) Views
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-16', 'studyFirstSubmitDate': '2017-03-30', 'studyFirstSubmitQcDate': '2017-08-23', 'lastUpdatePostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TEE simulation model decreases time to select image acquisition in trainee participant vs. participants trained by reading material only', 'timeFrame': '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)', 'description': 'The metrics for acquiring each image will be recorded by the model, the primary measurement will be time in seconds per view acquired.'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '2 week review 1 session for assessment- time required to acquire 10 views', 'description': 'Each image will be captured by the model and graded according to a 5 point scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Interactive web-base simulation'], 'conditions': ['Education', 'Training']}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Residents or fellows in anesthesia, cardiology and critical care enrolled at the Toronto General Hospital\n\nExclusion Criteria:\n\n* Residents or fellows in anesthesia, cardiology and critical care with prior experience with TEE probe manipulation'}, 'identificationModule': {'nctId': 'NCT03262532', 'acronym': 'Web-SimTEE', 'briefTitle': 'Assessment of a Web-Based Simulation in Transesophageal Echocardiography (TEE) Views', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Assessment of a Web-Based Simulation Module to Improve Performance in Obtaining Standard Transesophageal Echocardiography (TEE) Views', 'orgStudyIdInfo': {'id': 'REB 15-9547'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental', 'description': 'Learning TEE manipulation with a Web-based TEE simulation module', 'interventionNames': ['Other: Web-base simulator']}, {'label': 'Control', 'description': 'Learning a TEE manipulation without the Web-based TEE simulation', 'interventionNames': ['Other: No web-base simulator']}], 'interventions': [{'name': 'Web-base simulator', 'type': 'OTHER', 'description': 'Training manipulation of TEE using a Web-based simulator', 'armGroupLabels': ['Experimental']}, {'name': 'No web-base simulator', 'type': 'OTHER', 'description': 'Training manipulation of TEE with out a web-base simulator', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Annette Vegas, MD', 'role': 'CONTACT', 'email': 'annette.vegas@uhn.ca', 'phone': '416-340-4800', 'phoneExt': '5543'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}