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Virtual Reality Simulation for Teaching and Assessment of Anesthesia Crisis Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434002
Recruitment Status : Unknown
Verified February 2018 by University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Patient Simulation Other: Training by Virtual Reality Simulation Other: Training by Mannequin Based Simulation Not Applicable

Detailed Description:

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.

e Virtual reality simulation has been used successfully to teach technical skills such as laparoscopic surgery, carotid stenting, gall bladder surgery, and knee arthroscopy.

The specific aims of this project are:

  1. Build a multi-user, multi-site virtual reality simulator for anesthesia management and team training
  2. Evaluate the simulation as a tool for competency based medical education
  3. Compare the effectiveness of the simulator with mannequin based simulator for competency based medical education.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
  1. building the technical components for interaction within the virtual reality environment (phase 1);
  2. application of this virtual reality in medical training (phase 2) and
  3. measurement of training effectiveness with this Virtual Reality simulator against mannequin based training (phase 3).
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Virtual Reality Simulation for Teaching and Assessment of Anesthesia Crisis Management
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : January 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm-A
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
 Other: Training by Virtual Reality Simulation
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.
Experimental: Arm-B
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
 Other: Training by Mannequin Based Simulation
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of tasks correctly performed [ Time Frame: 1 hour ]

    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.

    The performance evaluation tool will assess the trainee's performance (i.e., medical management of Local Anesthetic Systemic Toxicity) per performance evaluation tool



Secondary Outcome Measures :
  1. use the Anesthesiologists' Non-Technical Skills (ANTS) tool [ Time Frame: 1 hour ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Anesthesia resident or fellow volunteers from University of Toronto

Exclusion Criteria:

  • Unwilling to enter the study
  • Previous experience with simulator based teaching on local anesthetic systemic toxicity
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434002


Contacts
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Contact: Vincent Chan 416-603-5118 vincent.chan@uhn.ca

Locations
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Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Vincent Chan    416-603-5118    vincent.chan@uhn.ca   
Sub-Investigator: Edward Kim         
Sub-Investigator: Ahtsham U Niazi         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Vincent Chan Toronto Western Hospital, University Health Network, University of Toronto
More Information
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Publications of Results:
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.
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.
Koutantji, Maria, et al.

Other Publications:
ACGME Outcome Project: Table of Toolbox Methods. (Accessed 1 Sept 2015, at http://njms.rutgers.edu/culweb/medical/documents/ToolboxofAssessmentMethods.pdf).

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03434002    
Other Study ID Numbers: 15-9985
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Virtual Reality Simulation
Teaching and Assessment
Anesthesia Crisis Management