Immersive Virtual Reality in Simulation-based Bronchoscopy Training

Sponsor
Copenhagen Academy for Medical Education and Simulation (Other)
Overall Status
Completed
CT.gov ID
NCT05078762
Collaborator
(none)
35
1
2
4.8
7.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Immersive Virtual Reality
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomization is performed online using SealedEnvelopeā„¢ (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 curveRandomization is performed online using SealedEnvelopeā„¢ (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 (Participant, 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.
Primary Purpose:
Other
Official Title:
Immersive Virtual Reality in Simulation-based Bronchoscopy Training - a Randomized Trial
Actual Study Start Date :
Oct 4, 2021
Actual Primary Completion Date :
Jan 30, 2022
Actual Study Completion Date :
Feb 28, 2022

Arms and Interventions

Arm Intervention/Treatment
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
Training in an iVR environment with Virtual Reality Goggles while using the bronchoscopy simulator, while the control group will train without VR goggles.
Other Names:
  • iVR
  • No Intervention: Non iVR

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

    Outcome Measures

    Primary Outcome Measures

    1. Structured Progress [From beginning to end of each procedure, aprox. 30 minutes]

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

    2. Procedure time [From beginning to end of each procedure, aprox. 30 minutes]

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

    Secondary Outcome Measures

    1. Motor Bronchoscopy Skill Score [From beginning to end of each procedure, aprox. 30 minutes]

      Objective and automatic composite score based on lower arm movement, measured with an Inertial Measurement Unit, and electromyography findings of hand and finger movement

    2. Diagnostic completeness [From beginning to end of each procedure, aprox. 30 minutes]

      The fraction in percent (%) of visited bronchial segments

    3. Heart Rate Variability(LF/HF ratio) [From beginning to end of each procedure, aprox. 30 minutes]

      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)

    4. Eye movement measurements [From beginning to end of each procedure, aprox. 30 minutes]

      Gaze direction (vector)

    5. Eye movement measurements [From beginning to end of each procedure, aprox. 30 minutes]

      Saccadic eye movements (gaze direction/time)

    6. Eye movement measurements [From beginning to end of each procedure, aprox. 30 minutes]

      Pupillary dilation (mm)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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:
    • Previous participation in trials involving bronchoscopy training.

    • Experience with independent bronchoscopy.

    • No informed consent.

    • Unable to speak Danish on a conversational level.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Copenhagen Academy for Medical Education and Simulation Copenhagen Denmark 2100

    Sponsors and Collaborators

    • Copenhagen Academy for Medical Education and Simulation

    Investigators

    • Study Chair: Lars Konge, Professor, MD, PHD, Copenhagen Academy for Medical Education and Simulation
    • Study Director: Flemming Bjerrum, MD, PhD, Copenhagen Academy for Medical Education and Simulation
    • Principal Investigator: Annarita G Andersen, BMed, Copenhagen Academy for Medical Education and Simulation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Annarita Ghosh Andersen, Principal investigator, Copenhagen Academy for Medical Education and Simulation
    ClinicalTrials.gov Identifier:
    NCT05078762
    Other Study ID Numbers:
    • iVRBronch
    First Posted:
    Oct 14, 2021
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Annarita Ghosh Andersen, Principal investigator, Copenhagen Academy for Medical Education and Simulation

    Study Results

    No Results Posted as of Mar 9, 2022