Does Training on a Virtual Reality Bronchoscopy Simulator Improve Performance of Bronchoscopic Intubation in Patients?

NCT ID: NCT02699242

Last Updated: 2017-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Traditionally, fiber optic bronchoscopy (FOB) intubation has been taught in a see one, do one basis. Modern training method in skill acquisition involves the use of simulators. Recently a portable, computer based, bronchoscopic simulator (ORSIM) was developed. The investigators hypothesized that operators trained with the ORSIM simulator will be more proficient in performing asleep FOB intubation than those trained with didactic teaching alone.

This randomized trial involves 34 consented residents or anesthesia assistants (AAs). In preparation, each consented person will view a teaching video of FOB intubation and tips. They will then perform an asleep FOBI in the OR under a staff anesthesiologist's supervision who's familiar with the study. Those who are randomized to the ORSIM group with undergo simulator training of 30-60 min. Those in the Didactic group will not undergo further training. Within about a week, the resident/AA will perform another asleep FOB intubation.

The study results will impact on how FOB intubation will be taught effectively in the future.

Conditions

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Endotracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Simulator arm

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.

Group Type EXPERIMENTAL

Simulator (ORSIM) training

Intervention Type DEVICE

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

Control arms

The control arm will be exposed only to the didactic teaching. The subjects will not undergo simulator training before undergoing 2nd fiber optic intubations.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Simulator (ORSIM) training

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Subject:

* anesthesia/surgery/emergency/critical care residents or anesthesia assistants who have performed less than 5 Fiberoptic intubations

Exclusion Criteria

* experience with bronchoscopy simulator or 5 or more FOB intubations

Patient:

* Anticipated difficult airway
* Mallampati Grade (MPG) \>III
* Body Mass Index (BMI) \>30
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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David Wong

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David T Wong, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 30234669 (View on PubMed)

Other Identifiers

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13-6321-BE

Identifier Type: -

Identifier Source: org_study_id

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