Immersive Virtual Reality in Simulation-based Bronchoscopy Training

Study Overview
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Brief Summary
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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

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

Conditions
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Virtual Reality, Medical Education

Intervention / Treatment
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* Other: Immersive Virtual Reality


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization is performed online using SealedEnvelope™ (Sealed Envelope ltd, London, UK) before the start of the trial. The participants are stratified by sex (man/woman) as this has been seen to influence skills acquisition during the early part of in the learning curve
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iVR<br>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<br>* Training in an iVR environment with Virtual Reality Goggles while using the bronchoscopy simulator, while the control group will train without VR goggles.<br>* Other names: iVR;|
| No Intervention: Non iVR<br>The control group will train on a bronchoscopy simulator without VR goggles. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchoscopy Training, Immersive Simulation Training