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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04451590
Other study ID # 108-2019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date December 2024

Study information

Verified date October 2023
Source Sunnybrook Health Sciences Centre
Contact Alam Fahad, MD, M.Sc
Phone 416-480-4864
Email fahad.alam@sunnybrook.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Intervention

Other:
VR-based simulation
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.
Mannequin-based simulation
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.

Locations

Country Name City State
Canada Sunnybrook Health Sciences Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Number of Required Practice Sessions Identify whether VR or mannequin-based simulation practice require fewer practice sessions to achieve learning objectives. During the 1 day practice session
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