Does Training on a Virtual Reality Bronchoscopy Simulator Improve Performance of Bronchoscopic Intubation in Patients?
1 other identifier
interventional
34
1 country
1
Brief Summary
The aim of the study is to study whether training by residents or anesthesia assistants, on a recently introduced virtual-reality bronchoscopic simulator (ORSIM) improves performance of fiberoptic intubation in patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 14, 2016
CompletedFirst Posted
Study publicly available on registry
March 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 21, 2017
June 1, 2017
1.2 years
February 14, 2016
June 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Performance of Fiberoptic intubation assessed by validated 40 point Global Rating Scale (GRS)
1 year
Secondary Outcomes (2)
Success/Failure of Fiberoptic intubation
1 year
The duration (in seconds) of the Fiberoptic intubation
1 year
Study Arms (2)
Simulator arm
EXPERIMENTALIn the Simulation arm group the subjects will be trained on the virtual reality bronchoscopic simulator (ORSIM simulator) for up to 60 minutes as active intervention, before they undertake the 2nd Fiber optic intubations.
Control arms
NO INTERVENTIONThe control arm will be exposed only to the didactic teaching. The subjects will not undergo simulator training before undergoing 2nd fiber optic intubations.
Interventions
The simulator/intervention group will undergo training on the virtual reality bronchoscopic simulator (ORSIM) for 60 minutes before the subjects perform the 2nd Fiber optic intubation
Eligibility Criteria
You may qualify if:
- Subject:
- anesthesia/surgery/emergency/critical care residents or anesthesia assistants who have performed less than 5 Fiberoptic intubations
You may not qualify if:
- experience with bronchoscopy simulator or 5 or more FOB intubations
- Patient:
- Anticipated difficult airway
- Mallampati Grade (MPG) \>III
- Body Mass Index (BMI) \>30
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Related Publications (1)
Wong DT, Mehta A, Singh KP, Leong SM, Ooi A, Niazi A, You-Ten E, Okrainec A, Patel R, Singh M, Wong J. The effect of virtual reality bronchoscopy simulator training on performance of bronchoscopic-guided intubation in patients: A randomised controlled trial. Eur J Anaesthesiol. 2019 Mar;36(3):227-233. doi: 10.1097/EJA.0000000000000890.
PMID: 30234669DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
David T Wong, MD
Department of Anesthesiology, Toronto Western Hospital, 399, Bathurst St., MC2-405, Toronto, ON, Canada M5T 1S8
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
February 14, 2016
First Posted
March 4, 2016
Study Start
April 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
June 21, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will share