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

Endotracheal Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699242
• Other study ID #: 13-6321-BE
• Status: Completed
• Phase: N/A
• First received: February 14, 2016
• Last updated: June 19, 2017
• Start date: April 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2017
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endotracheal Intubation

Intervention

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

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of Fiberoptic intubation assessed by validated 40 point Global Rating Scale (GRS)		1 year
Secondary	Success/Failure of Fiberoptic intubation		1 year
Secondary	The duration (in seconds) of the Fiberoptic intubation		1 year