NCT03434002

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

1.6 years

First QC Date

January 17, 2018

Last Update Submit

February 8, 2018

Conditions

Keywords

Virtual Reality SimulationTeaching and AssessmentAnesthesia Crisis Management

Outcome Measures

Primary Outcomes (1)

  • Number of tasks correctly performed

    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 Outcomes (1)

  • use the Anesthesiologists' Non-Technical Skills (ANTS) tool

    1 hour

Study Arms (2)

Arm-A

EXPERIMENTAL

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

Arm-B

EXPERIMENTAL

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

Interventions

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.

Arm-A

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.

Arm-B

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Anesthesia resident or fellow volunteers from University of Toronto

You may not qualify if:

  • Unwilling to enter the study
  • Previous experience with simulator based teaching on local anesthetic systemic toxicity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Related Publications (12)

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

    BACKGROUND
  • 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.

  • 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.

  • 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.

    RESULT
  • 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.

  • 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.

    RESULT
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Koutantji, Maria, et al.

    RESULT

Study Officials

  • Vincent Chan

    Toronto Western Hospital, University Health Network, University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2018

First Posted

February 15, 2018

Study Start

January 1, 2018

Primary Completion

August 1, 2019

Study Completion

January 1, 2020

Last Updated

February 15, 2018

Record last verified: 2018-02

Locations