Immersive Virtual Reality in Simulation-based Bronchoscopy Training

Immersive Virtual Reality in Simulation-based Bronchoscopy Training - a Randomized Trial

The purpose of this single-center randomized study is to investigate whether bronchoscopy training in an immersive Virtual Reality (iVR) environment will make the surgeon better at handling distractions and increase the quality of the bronchoscopy.

The participants will be stratified according to gender and randomized into two groups. Both groups will initially train on the bronchoscopy simulator without VR. Afterwards the intervention group will train in an iVR environment with Virtual Reality Goggles while using the bronchoscopy simulator, while the control group will train without VR goggles.

Afterwards both groups will be tested in the iVR environment in a test scenario

Study Overview

• Status: Completed
• Conditions: Medical Education; Virtual Reality
• Intervention / Treatment: Other: Immersive Virtual Reality

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Copenhagen Academy for Medical Education and Simulation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Residents working in Denmark in thoracic surgery and pulmonary medicine
• Participants are required to have a medical license.

Exclusion Criteria:

• Previous participation in trials involving bronchoscopy training.
• Experience with independent bronchoscopy.
• No informed consent.
• Unable to speak Danish on a conversational level.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iVR; The intervention group will train on a bronchoscopy simulator in an iVR environment with Virtual Reality Goggles (HTC IVE Pro Eye, HTC corporation, Taiwan) while using the bronchoscopy simulator.	Other: Immersive Virtual Reality; Training in an iVR environment with Virtual Reality Goggles while using the bronchoscopy simulator, while the control group will train without VR goggles.; Other Names: iVR
No Intervention: Non iVR; The control group will train on a bronchoscopy simulator without VR goggles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structured Progress	The systematic visualization and structured passage through the bronchial tree measured in points (0-18 points)	From beginning to end of each procedure, aprox. 30 minutes
Procedure time	Time (seconds) from passing the vocal cords to retraction of the endoscope.	From beginning to end of each procedure, aprox. 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Bronchoscopy Skill Score	Objective and automatic composite score based on lower arm movement, measured with an Inertial Measurement Unit, and electromyography findings of hand and finger movement	From beginning to end of each procedure, aprox. 30 minutes
Diagnostic completeness	The fraction in percent (%) of visited bronchial segments	From beginning to end of each procedure, aprox. 30 minutes
Heart Rate Variability(LF/HF ratio)	The fraction between the low frequency and high frequency heart rate, measured as R-R intervals on an electrocardiogram for five minutes (17) Kubios HRV version 2.216 (Biosignal Analysis and Medical Group, Kuopio, Finland)	From beginning to end of each procedure, aprox. 30 minutes
Eye movement measurements	Gaze direction (vector)	From beginning to end of each procedure, aprox. 30 minutes
Eye movement measurements	Saccadic eye movements (gaze direction/time)	From beginning to end of each procedure, aprox. 30 minutes
Eye movement measurements	Pupillary dilation (mm)	From beginning to end of each procedure, aprox. 30 minutes

Collaborators and Investigators

• Sponsor: Copenhagen Academy for Medical Education and Simulation
• Investigators: Study Chair: Lars Konge, Professor, MD, PHD, Copenhagen Academy for Medical Education and Simulation; Study Director: Flemming Bjerrum, MD, PhD, Copenhagen Academy for Medical Education and Simulation; Principal Investigator: Annarita G Andersen, BMed, Copenhagen Academy for Medical Education and Simulation

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Bronchoscopy Training; Immersive Simulation Training
• Other Study ID Numbers: iVRBronch

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No