NCT04451590

Brief Summary

Airway injury in patients is a high risk and complex medical crisis. Unfortunately, training for airway management in injured patients is challenging. The most effective way of practicing airway management is using mannequins. However, mannequin training is expensive and only occasionally available to medical trainees. The purpose of this study is to determine if Virtual Reality (VR) can be used to educate medical students on airway injury management. VR training will involve managing the care of a patient with an airway injury in an immersive, interactive VR hospital trauma bay. The investigators will compare the knowledge gained from VR training vs. mannequin training. The investigators will also investigate whether VR training teaches students faster than mannequin training. In addition, the investigators will identify factors which might affect learning from VR. Medical students who choose to participate will be randomized (i.e. participant will have a 50% chance to be placed in either group) to be trained with VR or a mannequin. Participants then will be trained on airway injury management using their assigned training approach. One week later, all participants will be assessed on their airway injury management skills using a mannequin. Before and after their sessions, participants will also be asked to complete a questionnaire on their clinical decision-making. Participants who received VR training will also complete a questionnaire about their experience with the VR training. This study will help develop a new approach to airway management training which is cheaper and more easily available to medical trainees than mannequin training. This educational tool could lead to better treatment of airway trauma in future patients.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Aug 2021Jun 2026

First Submitted

Initial submission to the registry

November 12, 2019

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

4.8 years

First QC Date

November 12, 2019

Last Update Submit

March 12, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Traumatic Airway Injury Management Knowledge

    Knowledge acquisition of traumatic airway injury management as assessed by the written Key Features Decision Making Checklist, Change from baseline (pre-training) knowledge to after practice session knowledge (post-training).

    up to 24 hours before and up to 24 hours after practice sessions

  • Application of Traumatic Airway Injury Management Knowledge

    Application of decision making concepts surrounding traumatic airway injury management as assessed by the Airway Injury Checklist of Core Decision Making Steps completed during participant performance of a simulated crisis assessment scenario.

    7 days after practice session

Secondary Outcomes (1)

  • Number of Required Practice Sessions

    During the 1 day practice session

Study Arms (2)

VR-based Simulation (Intervention)

EXPERIMENTAL

Students will receive training on traumatic airway management using VR-based simulation.

Other: VR-based simulation

Mannequin-based Simulation (Control)

OTHER

Students will receive training on traumatic airway management using mannequin-based simulation.

Other: Mannequin-based simulation

Interventions

Participants will experience a mannequin-based scenario practice which is the current gold standard in medical education. The trauma airway management scenario will match the VR environment and sequence of events.

Mannequin-based Simulation (Control)

Participants will experience a novel interactive and immersive VR full size trauma bay with an adult patient and healthcare professionals. Immersed in the environment, learners undertake the decision-making steps in managing the medical care for a patient with an airway injury. Learners are first given the case scenario from which they form their own learning goals/plans. They then navigate through the scenario that will provide feedback depending on their actions in the form of either the patient's hemodynamic changes or prompts from healthcare avatars in the scenario. These feedback processes are built-in and designed to promote reflection and reorganization of the learner's decision-making strategies. As learning progresses, fewer prompts will be given. At the end of the scenario, evaluation algorithms pre-programmed into the VR-based simulation will be displayed.

VR-based Simulation (Intervention)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 at time of consent
  • Medical student at U of T in 1st, 2nd or 3rd year
  • Able to attend two sessions a week apart

You may not qualify if:

  • Lack of participant consent or capacity to give consent
  • History of significant motion sickness (during exposure to physical, visual and virtual motion, cybersickness verbally declared by patient)
  • Visual/hearing impairments that affect abilities to listen/watch videos/VR video

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences

Toronto, Ontario, M4N 3M5, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
An external assessor will score videos participants performing Airway Trauma Management using the Airway Injury Checklist on Core Decision Making Steps. The assessors will be blinded to intervention.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2019

First Posted

June 30, 2020

Study Start

August 1, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

De-identified participant-level data will be made available upon reasonable request to study PI following publication of full trial results.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be available following publication.
Access Criteria
Data and supporting information will be made available following reasonable request directly to study PI.

Locations