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Completed

NCT Number: NCT05078762

Immersive Virtual Reality in Simulation-based Bronchoscopy Training

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

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Key information

Conditions

Virtual Reality Medical Education

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen Academy for Medical Education and Simulation

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: iVR

Primary outcomes

  1. Structured Progress

    Time frame: 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

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

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

Secondary outcomes

  1. Motor Bronchoscopy Skill Score

    Time frame: 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

    Time frame: 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)

    Time frame: 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

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

    Gaze direction (vector)

  5. Eye movement measurements

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

    Saccadic eye movements (gaze direction/time)

  6. Eye movement measurements

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

    Pupillary dilation (mm)

Sponsors and collaborators

Lead sponsor

Copenhagen Academy for Medical Education and Simulation

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2021
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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