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

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ClinicalTrials.gov Identifier: NCT02699242
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
David Wong, University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Endotracheal Intubation Device: Simulator (ORSIM) training Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Does Training on a Virtual Reality Bronchoscopy Simulator Improve Performance of Bronchoscopic Intubation in Patients?
Study Start Date : April 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: 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.
Device: 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

No Intervention: 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.



Primary Outcome Measures :
  1. Performance of Fiberoptic intubation assessed by validated 40 point Global Rating Scale (GRS) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Success/Failure of Fiberoptic intubation [ Time Frame: 1 year ]
  2. The duration (in seconds) of the Fiberoptic intubation [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699242


Locations
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: David T Wong, MD Department of Anesthesiology, Toronto Western Hospital, 399, Bathurst St., MC2-405, Toronto, ON, Canada M5T 1S8

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Wong, Anesthesiologist, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02699242     History of Changes
Other Study ID Numbers: 13-6321-BE
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by David Wong, University Health Network, Toronto:
Fiberoptic intubation Training Simulation Performance