Virtual RealityNCT05078762
Immersive Virtual Reality in Simulation-based Bronchoscopy Training
A study testing Immersive Virtual Reality in people with Virtual Reality and Medical Education, run by Copenhagen Academy for Medical Education and Simulation at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Medical Education
- What is being tested?
- Immersive Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Oct 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Residents working in Denmark in thoracic surgery and pulmonary medicine
- Participants are required to have a medical license.
Who cannot join
- Previous participation in trials involving bronchoscopy training.
- Experience with independent bronchoscopy.
- No informed consent.
- Unable to speak Danish on a conversational level.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen Academy for Medical Education and Simulation
Copenhagen, 2100
About this study
Official title: Immersive Virtual Reality in Simulation-based Bronchoscopy Training - a Randomized Trial
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
- Being tested
- Immersive Virtual Reality
- Keywords
- Bronchoscopy Training, Immersive Simulation Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual RealityOther
Also called iVR
Training in an iVR environment with Virtual Reality Goggles while using the bronchoscopy simulator, while the control group will train without VR goggles.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Immersive Virtual Reality |
| Non iVR | No intervention | The control group will train on a bronchoscopy simulator without VR goggles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structured Progress
The systematic visualization and structured passage through the bronchial tree measured in points (0-18 points)
Measured: From beginning to end of each procedure, aprox. 30 minutes
Procedure time
Time (seconds) from passing the vocal cords to retraction of the endoscope.
Measured: From beginning to end of each procedure, aprox. 30 minutes
Secondary outcomes (6)
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
Measured: From beginning to end of each procedure, aprox. 30 minutes
Diagnostic completeness
The fraction in percent (%) of visited bronchial segments
Measured: From beginning to end of each procedure, aprox. 30 minutes
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)
Measured: From beginning to end of each procedure, aprox. 30 minutes
Eye movement measurements
Gaze direction (vector)
Measured: From beginning to end of each procedure, aprox. 30 minutes
Eye movement measurements
Saccadic eye movements (gaze direction/time)
Measured: From beginning to end of each procedure, aprox. 30 minutes
Eye movement measurements
Pupillary dilation (mm)
Measured: From beginning to end of each procedure, aprox. 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start4 Oct 2021
- Primary completion30 Jan 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen Academy for Medical Education and Simulation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annarita Ghosh Andersen, Copenhagen Academy for Medical Education and Simulation
- Investigators
- Lars Konge, Professor, MD, PHD, Study chair, Copenhagen Academy for Medical Education and SimulationFlemming Bjerrum, MD, PhD, Study director, Copenhagen Academy for Medical Education and SimulationAnnarita G Andersen, BMed, Principal investigator, Copenhagen Academy for Medical Education and Simulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078762
- Sponsor's protocol ID
- iVRBronch
- Status last verified
- Mar 2022
- First submitted
- 22 Sep 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Virtual Reality in Simulation-based Bronchoscopy Training - a Randomized Trial
- ClinicalTrials.gov ID
- NCT05078762
- Acronym / sponsor ID
- iVRBronch
- Conditions
- Virtual Reality, Medical Education
- Keywords
- Bronchoscopy Training, Immersive Simulation Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Copenhagen Academy for Medical Education and SimulationUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| iVR | Experimental | Other: Immersive Virtual RealityThe 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. |
| Non iVR | No intervention | –The control group will train on a bronchoscopy simulator without VR goggles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Residents working in Denmark in thoracic surgery and pulmonary medicine
- Participants are required to have a medical license.
Key exclusion criteria (4 listed)
- Previous participation in trials involving bronchoscopy training.
- Experience with independent bronchoscopy.
- No informed consent.
- Unable to speak Danish on a conversational level.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual RealityAlso: iVRTraining in an iVR environment with Virtual Reality Goggles while using the bronchoscopy simulator, while the control group will train without VR goggles. | Other | iVR |
Primary outcome
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)
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.
6 secondary outcomes
Motor Bronchoscopy Skill Score
Time frame: From beginning to end of each procedure, aprox. 30 minutes
Diagnostic completeness
Time frame: From beginning to end of each procedure, aprox. 30 minutes
Heart Rate Variability(LF/HF ratio)
Time frame: From beginning to end of each procedure, aprox. 30 minutes
Eye movement measurements
Time frame: From beginning to end of each procedure, aprox. 30 minutes
Eye movement measurements
Time frame: From beginning to end of each procedure, aprox. 30 minutes
Eye movement measurements
Time frame: From beginning to end of each procedure, aprox. 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality in people with Virtual Reality and Medical Education, run by Copenhagen Academy for Medical Education and Simulation at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structured Progress (time frame: From beginning to end of each procedure, aprox. 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.