NCT04591041

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

August 24, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

1.6 years

First QC Date

September 2, 2020

Last Update Submit

September 10, 2022

Conditions

Simulation of Physical IllnessEducational Problems

Keywords

Mixed Reality

Outcome Measures

Primary Outcomes (1)

  • 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.

    one week post exposure

Secondary Outcomes (3)

  • Usability Score

    Immediately after exposure

  • Learning Satisfaction Score

    Immediately after exposure

  • Time required to complete critical crisis related tasks

    one week post exposure

Study Arms (2)

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

Interventions

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 Mixed Reality Simulation
Training by Mannequin Based SimulationOTHER

Medical students will train a via traditional mannequin based medical crisis scenario

Training by Mannequin Based Simulation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • University of Toronto Medical student volunteers

You may not qualify if:

  • Unwilling to enter the study
  • Deficit of vision or hearing incompatible with Microsoft Hololens 2 use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4E 3M4, Canada

RECRUITING

Central Study Contacts

Julian Wiegelmann

CONTACT

4164804864julian.wiegelmann@sunnybrook.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

September 2, 2020

First Posted

October 19, 2020

Study Start

August 24, 2021

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

September 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)