Simulation of Physical IllnessHoloSIMNCT04591041
HoloSIM: Mixed Reality Medical Student Training in Complex Crisis Scenarios
A study testing HoloSIM Software via Hololens 2 and Training by Mannequin Based Simulation in people with Simulation of Physical Illness and Educational Problems, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
In this study, Investigators will test a mixed reality software platform to improve and help for teaching and assessment of anesthesia crisis management among medical students. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Simulation of Physical Illness, Educational Problems
- What is being tested?
- HoloSIM Software via Hololens 2 and Training by Mannequin Based Simulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 24 Aug 2021to 1 Apr 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- University of Toronto Medical student volunteers
Who cannot join
- Unwilling to enter the study
- Deficit of vision or hearing incompatible with Microsoft Hololens 2 use
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4E 3M4
Julian R Wiegelmann, MD, 416-480-4864, julian.wiegelmann@sunnybrook.ca
About this study
Official title: HoloSIM: The Way Forward in Complex Crisis Training
In this study, Investigators will test a mixed reality software platform to improve and help for teaching and assessment of anesthesia crisis management among medical students.
- Being tested
- HoloSIM Software via Hololens 2, Training by Mannequin Based Simulation
- Keywords
- Mixed Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoloSIM Software via Hololens 2Device
Medical students will train via a mixed reality simulated crisis scenario using the HoloSIM software on the Microsoft Hololens 2
Training by Mannequin Based SimulationOther
Medical students will train a via traditional mannequin based medical crisis scenario
| Study group | Role | What they receive |
|---|---|---|
| Training by Mixed Reality Simulation | Experimental | Not described Receives: Device: HoloSIM Software via Hololens 2 |
| Training by Mannequin Based Simulation | Active comparator | Not described Receives: Other: Training by Mannequin Based Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anaphylaxis Checklist of Core Decision Making Steps
Expert consensus based checklists of critical scenario actions on a mannequin based crisis scenario. Student scenario performance graded from 0 to 45, with higher scores representing a better performance.
Measured: one week post exposure
Secondary outcomes (3)
Usability Score
Likert scale (5 point) based assessment of software usability. Higher scores on a scale of 1 to 5 represent a better software system usability.
Measured: Immediately after exposure
Learning Satisfaction Score
Likert scale (5 point) based assessment of learning satisfaction. Higher scores on a scale of 1 to 5 represent a greater degree of learning satisfaction.
Measured: Immediately after exposure
Time required to complete critical crisis related tasks
Measured time until critical scenario management events occur
Measured: one week post exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start24 Aug 2021
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation of Physical IllnessStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Wiegelmann, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591041
- Sponsor's protocol ID
- SUN-2124
- Acronym
- HoloSIM
- Status last verified
- Sep 2022
- First submitted
- 2 Sep 2020
- Last updated
- 13 Sep 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 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HoloSIM: The Way Forward in Complex Crisis Training
- ClinicalTrials.gov ID
- NCT04591041
- Acronym / sponsor ID
- HoloSIM / SUN-2124
- Keywords
- Mixed Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 19 Oct 2020 (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.
In this study, Investigators will test a mixed reality software platform to improve and help for teaching and assessment of anesthesia crisis management among medical students.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training by Mixed Reality Simulation | Experimental | Device: HoloSIM Software via Hololens 2 |
| Training by Mannequin Based Simulation | Active comparator | Other: Training by Mannequin Based Simulation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- University of Toronto Medical student volunteers
Key exclusion criteria (2 listed)
- Unwilling to enter the study
- Deficit of vision or hearing incompatible with Microsoft Hololens 2 use
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 |
|---|---|---|
| HoloSIM Software via Hololens 2Medical students will train via a mixed reality simulated crisis scenario using the HoloSIM software on the Microsoft Hololens 2 | Device | Training by Mixed Reality Simulation |
| Training by Mannequin Based SimulationMedical students will train a via traditional mannequin based medical crisis scenario | Other | Training by Mannequin Based Simulation |
Primary outcome
Anaphylaxis Checklist of Core Decision Making Steps
Time frame: one week post exposure
Expert consensus based checklists of critical scenario actions on a mannequin based crisis scenario. Student scenario performance graded from 0 to 45, with higher scores representing a better performance.
3 secondary outcomes
Usability Score
Time frame: Immediately after exposure
Learning Satisfaction Score
Time frame: Immediately after exposure
Time required to complete critical crisis related tasks
Time frame: one week post exposure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
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Recruiting
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HoloSIM Software via Hololens 2 and Training by Mannequin Based Simulation in people with Simulation of Physical Illness and Educational Problems, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Sep 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julian Wiegelmann (4164804864, julian.wiegelmann@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anaphylaxis Checklist of Core Decision Making Steps (time frame: one week post exposure). 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 13 Sep 2022.