Immersive Virtual Reality in Simulation-based Bronchoscopy Training

NCT05078762 | Completed

• 1 other identifier: iVRBronch
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Virtual Reality; Medical Education

Keywords

Bronchoscopy Training; Immersive Simulation Training

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Motor Bronchoscopy Skill Score

  From beginning to end of each procedure, aprox. 30 minutes

• Diagnostic completeness

  From beginning to end of each procedure, aprox. 30 minutes

• Heart Rate Variability(LF/HF ratio)

  From beginning to end of each procedure, aprox. 30 minutes

• Eye movement measurements

  From beginning to end of each procedure, aprox. 30 minutes

• Eye movement measurements

  From beginning to end of each procedure, aprox. 30 minutes

Study Arms (2)

iVR

EXPERIMENTAL

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

Non iVR

NO INTERVENTION

The control group will train on a bronchoscopy simulator without VR goggles.

Interventions

Immersive Virtual Reality OTHER

Training in an iVR environment with Virtual Reality Goggles while using the bronchoscopy simulator, while the control group will train without VR goggles.

Also known as: iVR

iVR

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Based on a self-report form
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Copenhagen Academy for Medical Education and Simulation: lead

Study Sites (1)

Copenhagen Academy for Medical Education and Simulation

Copenhagen, 2100, Denmark

Location

Study Officials

• Lars Konge, Professor, MD, PHD

  Copenhagen Academy for Medical Education and Simulation

  STUDY CHAIR

• Flemming Bjerrum, MD, PhD

  Copenhagen Academy for Medical Education and Simulation

  STUDY DIRECTOR

• Annarita G Andersen, BMed

  Copenhagen Academy for Medical Education and Simulation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants will not be blinded to the main investigator, as this is impossible due to the nature of the trial. The statistical analysis will be performed blinded and by someone other than the principal investigator.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 14, 2021
• Study Start: October 4, 2021
• Primary Completion: January 30, 2022
• Study Completion: February 28, 2022
• Last Updated: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)