- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05446896
Effectiveness of AR in Ventilator Setting Education. (AR)
Setting-up Of A Mechanical Ventilator With An Augmented Reality Guide: A Prospective, Randomized Pilot Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Recently, the demand for mechanical ventilation (MV) has increased with the COVID-19 pandemic; however, the conventional approaches to MV training are resource-intensive and require on-site training. Consequently, the need for independent learning platforms with remote assistance in institutions without resources has surged.
Objective:
This study aimed to determine the feasibility and effectiveness of an augmented reality (AR)-based self-learning platform for novices to set up a ventilator without on-site assistance.
Method:
This was a prospective randomized controlled pilot study conducted at Samsung Medical Center, Korea from January to February 2022. Nurses with no prior experience of MV or AR were enrolled. We randomized the participants into two groups: manual and AR groups. Participants in the manual group used a printed manual and made a phone call for assistance, whereas participants in the AR group were guided by AR-based instructions and requested assistance with the head-mounted device (HMD). We compared the overall score of the procedure, required level of assistance, and user's experience between the groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 06351
- Samsung Medical Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
We enrolled nurses who had no prior experience with ventilator setup or AR systems, regardless of their work department or age.
Exclusion Criteria:
We excluded nurses who had already experienced setting up a ventilator or who had trouble wearing or using a head-mounted device (HMD).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AR group
participants in the AR group were guided by AR-based instructions and requested assistance with the head-mounted device.
|
The AR instructions were developed as a step-by-step guide with the same text and images as in the printed manual, utilizing the dynamic 365 Guide (Software, Microsoft Corporation, Redmond, WA, USA).
The AR instructions were delivered using the Microsoft HoloLens 2.
|
|
No Intervention: manual group
Participants in the manual group used a printed manual and made a phone call for assistance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the overall score of the procedure
Time Frame: 30 minutes
|
a 100-point scale converted from the original score.
The participants scored 1 point for each step if they successfully finished the step within five minutes and obtained a maximum score of 35.
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the required level of assistance
Time Frame: 30 minutes
|
The number of steps needed assistance to complete the procedure
|
30 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Usability
Time Frame: 30 minutes
|
System usability scale
|
30 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Meong Hi Son, MD, Department of Pediatrics Samsung Medical Center and Sungkyunkwan University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021-12-112-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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