Clinical trial NCT05870137: Assessing Mixed Reality for Emergency Medical Care Delivery in a Simulated Environment
Official title: A Pilot Randomised Cross-over Trial of HoloLens2™️ for the Delivery of Distributed Medical Care During COVID-19 in a Simulated Environment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergency Medicine
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised cross-over trial
Primary purpose: TREATMENT

Brief summary: This study assessed the feasibility and effectiveness of using Mixed Reality (MR) through the use of HoloLens2TM technology to enhance emergency clinical care delivery in a simulated environment. This was achieved by inviting 22 resident grade doctors to complete two scenarios. Each scenario was supported either by standard care methods or Mixed reality. The participants were randomised to at the start of the scenarios to determine which support they would receive first. The main outcome was to see if there was difference in error rates. This was assessed using the ICECAP multidimensional error capture tool. Secondary outcomes included teamwork, scenario completion, stress/cognitive load, and Mixed reality device user acceptability.


Eligibility criteria: Inclusion Criteria:

* All participants must provide consent to participate in the study
* Participants must receive a standardised HL2 headset and operational tutorial
* Participants must complete a qualitative questionnaire to determine their clinical experience and exposure to the technology prior to commencement of the study
* Participants must pass a competency test to ensure standardised basic technical competency and mitigate device related first-use learning effects

Exclusion Criteria:

* Not currently working in emergency medicine/trauma setting
* No prior course completion (Advance trauma and Basic Life support)

Prior to the commencement of the study, all eligible participants were required to provide their consent to participate. Participants were then provided with a standardized HL2 headset and operational tutorial, and completed a qualitative questionnaire to assess their clinical experience and exposure to the technology. The tutorial, which was guided by the research team, included a practical induction providing fundamentals of use, how to make and receive calls, and how to use the clinical data assets provided. Participants were also required to pass a competency test to ensure standardized basic technical competency and mitigate device-related first-use learning effects.

Primary outcomes:
measure: Error Rate
timeFrame: Through study completion, an average of 8 minutes per scenario
Secondary outcomes:
measure: Scenario completion success
timeFrame: Through study completion, an average of 8 minutes per scenario
measure: Scenario completion duration
timeFrame: Through study completion, an average of 8 minutes per scenario
measure: Team performance
timeFrame: Through study completion, an average of 8 minutes per scenario
measure: Team performance
timeFrame: Through study completion, an average of 8 minutes per scenario
measure: Team workload
timeFrame: Through study completion, an average of 8 minutes per scenario
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Department of Surgery and Cancer Imperial College London
Study officials:
affiliation: Senior Lecturer in Surgery and Consultant Surgeon
name: James Kinross, PhD FRCS
role: PRINCIPAL_INVESTIGATOR
References: