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Immersive Virtual Reality in Simulation-based Bronchoscopy Training

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05078762
Enrollment
35
Registered
2021-10-14
Start date
2021-10-04
Completion date
2022-02-28
Last updated
2022-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical Education, Virtual Reality

Keywords

Bronchoscopy Training, Immersive Simulation Training

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

Interventions

OTHERImmersive 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.

Sponsors

Copenhagen Academy for Medical Education and Simulation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention 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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Structured ProgressFrom beginning to end of each procedure, aprox. 30 minutesThe systematic visualization and structured passage through the bronchial tree measured in points (0-18 points)
Procedure timeFrom beginning to end of each procedure, aprox. 30 minutesTime (seconds) from passing the vocal cords to retraction of the endoscope.

Secondary

MeasureTime frameDescription
Motor Bronchoscopy Skill ScoreFrom beginning to end of each procedure, aprox. 30 minutesObjective and automatic composite score based on lower arm movement, measured with an Inertial Measurement Unit, and electromyography findings of hand and finger movement
Diagnostic completenessFrom beginning to end of each procedure, aprox. 30 minutesThe fraction in percent (%) of visited bronchial segments
Heart Rate Variability(LF/HF ratio)From beginning to end of each procedure, aprox. 30 minutesThe 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)
Eye movement measurementsFrom beginning to end of each procedure, aprox. 30 minutesGaze direction (vector)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026