Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT03434002
Status:
UNKNOWN
Last Update Posted:
2018-02-15
First Post:
2018-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual Reality Simulation for Teaching and Assessment of Anesthesia Crisis Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '1. building the technical components for interaction within the virtual reality environment (phase 1);\n2. application of this virtual reality in medical training (phase 2) and\n3. measurement of training effectiveness with this Virtual Reality simulator against mannequin based training (phase 3).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-08', 'studyFirstSubmitDate': '2018-01-17', 'studyFirstSubmitQcDate': '2018-02-08', 'lastUpdatePostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of tasks correctly performed', 'timeFrame': '1 hour', 'description': "The primary outcome in performance evaluation is the number of tasks correctly performed during management of the Local Anesthetic Systemic Toxicity event. Investigators will use the same performance evaluation tool.\n\nThe performance evaluation tool will assess the trainee's performance (i.e., medical management of Local Anesthetic Systemic Toxicity) per performance evaluation tool"}], 'secondaryOutcomes': [{'measure': "use the Anesthesiologists' Non-Technical Skills (ANTS) tool", 'timeFrame': '1 hour', 'description': "The Investigators will use the anesthesiologists' non-technical skills (ANTS) tool in the Local Anesthetic Systemic Toxicity Event (Data Collection Tools, Supplemental Digital Content 2, http://links.lww.com/AAP/A45) as described by Neal."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality Simulation', 'Teaching and Assessment', 'Anesthesia Crisis Management'], 'conditions': ['Patient Simulation']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'ACGME Outcome Project: Table of Toolbox Methods. (Accessed 1 Sept 2015, at http://njms.rutgers.edu/culweb/medical/documents/ToolboxofAssessmentMethods.pdf).'}, {'pmid': '20078756', 'type': 'RESULT', 'citation': 'McGaghie WC, Issenberg SB, Petrusa ER, Scalese RJ. A critical review of simulation-based medical education research: 2003-2009. Med Educ. 2010 Jan;44(1):50-63. doi: 10.1111/j.1365-2923.2009.03547.x.'}, {'pmid': '18828828', 'type': 'RESULT', 'citation': 'Salas E, DiazGranados D, Weaver SJ, King H. Does team training work? Principles for health care. Acad Emerg Med. 2008 Nov;15(11):1002-9. doi: 10.1111/j.1553-2712.2008.00254.x. Epub 2008 Oct 1.'}, {'type': 'RESULT', 'citation': 'Sorbero ME, Farley DO, Mattke S, Lovejoy S. Outcome measures for effective teamwork in inpatient care (RAND technical report TR-462-AHRQ). Arlington, VA: RAND Corporation, 2008.'}, {'pmid': '16011941', 'type': 'RESULT', 'citation': 'Ziv A, Ben-David S, Ziv M. Simulation based medical education: an opportunity to learn from errors. Med Teach. 2005 May;27(3):193-9. doi: 10.1080/01421590500126718.'}, {'type': 'RESULT', 'citation': 'Alonso A, Baker DP, Holtzman A, et al. Reducing medical error in the military health system: How can team training help? Hum Resour Manag Rev. 2006;16:396-415.'}, {'pmid': '22179792', 'type': 'RESULT', 'citation': 'Leblanc VR. Review article: simulation in anesthesia: state of the science and looking forward. Can J Anaesth. 2012 Feb;59(2):193-202. doi: 10.1007/s12630-011-9638-8. Epub 2011 Dec 17.'}, {'pmid': '21900138', 'type': 'RESULT', 'citation': 'Cook DA, Hatala R, Brydges R, Zendejas B, Szostek JH, Wang AT, Erwin PJ, Hamstra SJ. Technology-enhanced simulation for health professions education: a systematic review and meta-analysis. JAMA. 2011 Sep 7;306(9):978-88. doi: 10.1001/jama.2011.1234.'}, {'pmid': '14760660', 'type': 'RESULT', 'citation': 'Grantcharov TP, Kristiansen VB, Bendix J, Bardram L, Rosenberg J, Funch-Jensen P. Randomized clinical trial of virtual reality simulation for laparoscopic skills training. Br J Surg. 2004 Feb;91(2):146-50. doi: 10.1002/bjs.4407.'}, {'pmid': '25911460', 'type': 'RESULT', 'citation': 'Nguyen N, Elliott JO, Watson WD, Dominguez E. Simulation Improves Nontechnical Skills Performance of Residents During the Perioperative and Intraoperative Phases of Surgery. J Surg Educ. 2015 Sep-Oct;72(5):957-63. doi: 10.1016/j.jsurg.2015.03.005. Epub 2015 Apr 21.'}, {'pmid': '22157743', 'type': 'RESULT', 'citation': 'Neal JM, Hsiung RL, Mulroy MF, Halpern BB, Dragnich AD, Slee AE. ASRA checklist improves trainee performance during a simulated episode of local anesthetic systemic toxicity. Reg Anesth Pain Med. 2012 Jan-Feb;37(1):8-15. doi: 10.1097/AAP.0b013e31823d825a.'}, {'type': 'RESULT', 'citation': 'Koutantji, Maria, et al.'}]}, 'descriptionModule': {'briefSummary': 'In this study, Investigators are going to develop and test a device to apply virtual reality simulation to improve and help for teaching and assessment of anesthesia crisis management.', 'detailedDescription': 'Competency based medical education (CBME) is an outcomes-based approach to the design, implementation, assessment, and evaluation of medical education. The goals of Competency Based Medical Education are to improve patient safety, patient health outcomes, and enhance the competence and performance of individuals, groups and teams. Simulation-based training is a proven effective method to improve the skills and competency of the student by permit-ting repetitive practice before an actual procedure is performed on real patients.\n\ne Virtual reality simulation has been used successfully to teach technical skills such as laparoscopic surgery, carotid stenting, gall bladder surgery, and knee arthroscopy.\n\nThe specific aims of this project are:\n\n1. Build a multi-user, multi-site virtual reality simulator for anesthesia management and team training\n2. Evaluate the simulation as a tool for competency based medical education\n3. Compare the effectiveness of the simulator with mannequin based simulator for competency based medical education.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anesthesia resident or fellow volunteers from University of Toronto\n\nExclusion Criteria:\n\n* Unwilling to enter the study\n* Previous experience with simulator based teaching on local anesthetic systemic toxicity'}, 'identificationModule': {'nctId': 'NCT03434002', 'briefTitle': 'Virtual Reality Simulation for Teaching and Assessment of Anesthesia Crisis Management', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Virtual Reality Simulation for Teaching and Assessment of Anesthesia Crisis Management', 'orgStudyIdInfo': {'id': '15-9985'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm-A', 'description': 'Randomized 15 residents out of 30 Post Graduate Year 1 or 2 anesthesia residents (not involved in initial Virtual Reality testing) will be receive Local Anesthetic Systemic Toxicity simulation training by Virtual Reality simulation', 'interventionNames': ['Other: Training by Virtual Reality Simulation']}, {'type': 'EXPERIMENTAL', 'label': 'Arm-B', 'description': 'Randomized other 15 residents out of 30 Post Graduate Year 1 or 2 anesthesia residents (not involved in initial Virtual Reality testing) will be receive Local Anesthetic Systemic Toxicity simulation training by mannequin based simulation', 'interventionNames': ['Other: Training by Mannequin Based Simulation']}], 'interventions': [{'name': 'Training by Virtual Reality Simulation', 'type': 'OTHER', 'description': 'Those Randomized 15 residents will be receive Local Anesthetic Systemic Toxicity simulation training by Virtual Reality simulation and after two weeks, they will be evaluated by investigators by using the same performance evaluation tool.', 'armGroupLabels': ['Arm-A']}, {'name': 'Training by Mannequin Based Simulation', 'type': 'OTHER', 'description': 'Randomized other 15 residents will be receive Local Anesthetic Systemic Toxicity simulation training by mannequin based simulation and after two weeks, they will be evaluated by investigators by using the same performance evaluation tool.', 'armGroupLabels': ['Arm-B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Vincent Chan', 'role': 'CONTACT', 'email': 'vincent.chan@uhn.ca', 'phone': '416-603-5118'}, {'name': 'Edward Kim', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ahtsham U Niazi', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Vincent Chan', 'role': 'CONTACT', 'email': 'vincent.chan@uhn.ca', 'phone': '416-603-5118'}], 'overallOfficials': [{'name': 'Vincent Chan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto Western Hospital, University Health Network, University of Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}