NCT05446896

Brief Summary

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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 24, 2022

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
Last Updated

July 7, 2022

Status Verified

June 1, 2022

Enrollment Period

4 days

First QC Date

June 25, 2022

Last Update Submit

June 30, 2022

Conditions

Keywords

Ventilator, Nursing, Education, Augmented reality

Outcome Measures

Primary Outcomes (1)

  • the overall score of the procedure

    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 Outcomes (1)

  • the required level of assistance

    30 minutes

Other Outcomes (1)

  • Usability

    30 minutes

Study Arms (2)

AR group

EXPERIMENTAL

participants in the AR group were guided by AR-based instructions and requested assistance with the head-mounted device.

Device: AR guidance with Hololens 2

manual group

NO INTERVENTION

Participants in the manual group used a printed manual and made a phone call for assistance.

Interventions

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.

AR group

Eligibility Criteria

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

You may qualify if:

  • We enrolled nurses who had no prior experience with ventilator setup or AR systems, regardless of their work department or age.

You may not qualify if:

  • We excluded nurses who had already experienced setting up a ventilator or who had trouble wearing or using a head-mounted device (HMD).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Centre

Seoul, 06351, South Korea

Location

Related Publications (1)

  • Heo S, Moon S, Kim M, Park M, Cha WC, Son MH. An Augmented Reality-Based Guide for Mechanical Ventilator Setup: Prospective Randomized Pilot Trial. JMIR Serious Games. 2022 Jul 22;10(3):e38433. doi: 10.2196/38433.

Study Officials

  • Meong Hi Son, MD

    Department of Pediatrics Samsung Medical Center and Sungkyunkwan University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 25, 2022

First Posted

July 7, 2022

Study Start

January 24, 2022

Primary Completion

January 28, 2022

Study Completion

January 28, 2022

Last Updated

July 7, 2022

Record last verified: 2022-06

Locations