NCT02699242

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

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

1.2 years

First QC Date

February 14, 2016

Last Update Submit

June 19, 2017

Conditions

Keywords

Fiberoptic intubation Training Simulation Performance

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

EXPERIMENTAL

In 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.

Device: Simulator (ORSIM) training

Control arms

NO INTERVENTION

The 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

Simulator arm

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

Study Officials

  • David T Wong, MD

    Department of Anesthesiology, Toronto Western Hospital, 399, Bathurst St., MC2-405, Toronto, ON, Canada M5T 1S8

    PRINCIPAL INVESTIGATOR

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

Locations