Virtual Reality Simulation for Teaching and Assessment of Anesthesia Crisis Management

February 8, 2018 updated by: University Health Network, Toronto
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Toronto Western Hospital
        • Contact:
        • Sub-Investigator:
          • Edward Kim
        • Sub-Investigator:
          • Ahtsham U Niazi

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Vincent Chan, Toronto Western Hospital, University Health Network, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2018

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

January 17, 2018

First Submitted That Met QC Criteria

February 8, 2018

First Posted (Actual)

February 15, 2018

Study Record Updates

Last Update Posted (Actual)

February 15, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15-9985

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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