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CompletedNCT05078762Updated Mar 9, 2022

Immersive Virtual Reality in Simulation-based Bronchoscopy Training

An interventional study of Immersive Virtual Reality in Virtual Reality and Medical Education, sponsored by Copenhagen Academy for Medical Education and Simulation. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-09.

Sponsored by Copenhagen Academy for Medical Education and Simulation · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Virtual Reality
  • Medical Education

Keywords

  • Bronchoscopy Training
  • Immersive Simulation Training
03

In context

Lead sponsor

Copenhagen Academy for Medical Education and Simulation is the lead sponsor of 27 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Previous participation in trials involving bronchoscopy training.
  • Experience with independent bronchoscopy.
  • No informed consent.
  • Unable to speak Danish on a conversational level.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
35 participants (actual)

Study arms

  • 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

  • No intervention
    Non iVR

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

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.

    Also known as: iVR

06

What researchers measure

Primary outcomes

  1. Structured Progress

    The systematic visualization and structured passage through the bronchial tree measured in points (0-18 points)

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

  2. Procedure time

    Time (seconds) from passing the vocal cords to retraction of the endoscope.

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

Secondary outcomes

  1. 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

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

  2. Diagnostic completeness

    The fraction in percent (%) of visited bronchial segments

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

  3. 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)

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

  4. Eye movement measurements

    Gaze direction (vector)

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

  5. Eye movement measurements

    Saccadic eye movements (gaze direction/time)

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

  6. Eye movement measurements

    Pupillary dilation (mm)

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

07

Study locations

1 site
  • Copenhagen Academy for Medical Education and Simulation
    Copenhagen, 2100, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05078762
Lead sponsor
Copenhagen Academy for Medical Education and Simulation
Responsible party
Annarita Ghosh Andersen (Principal investigator, Copenhagen Academy for Medical Education and Simulation) — Principal investigator
First posted
Oct 14, 2021
Start date
Oct 4, 2021
Primary completion
Jan 30, 2022
Completion
Feb 28, 2022
Last update
Mar 9, 2022

Study contacts

Lars Konge, Professor, MD, PHD
study chair · Copenhagen Academy for Medical Education and Simulation
Flemming Bjerrum, MD, PhD
study director · Copenhagen Academy for Medical Education and Simulation
Annarita G Andersen, BMed
principal investigator · Copenhagen Academy for Medical Education and Simulation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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