Immersive Virtual Reality in Simulation-based Bronchoscopy Training

Virtual Reality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05078762
• Other study ID #: iVRBronch
• Status: Completed
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: Copenhagen Academy for Medical Education and Simulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 28, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Medical Education
• Virtual Reality

Intervention

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.

Locations

Country	Name	City	State
Denmark	Copenhagen Academy for Medical Education and Simulation	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen Academy for Medical Education and Simulation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Diagnostic completeness	The fraction in percent (%) of visited bronchial segments	From beginning to end of each procedure, aprox. 30 minutes
Secondary	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
Secondary	Eye movement measurements	Gaze direction (vector)	From beginning to end of each procedure, aprox. 30 minutes
Secondary	Eye movement measurements	Saccadic eye movements (gaze direction/time)	From beginning to end of each procedure, aprox. 30 minutes
Secondary	Eye movement measurements	Pupillary dilation (mm)	From beginning to end of each procedure, aprox. 30 minutes