Effectiveness of AR in Ventilator Setting Education. (AR)

June 30, 2022 updated by: Meong Hi Son, Samsung Medical Center

Setting-up Of A Mechanical Ventilator With An Augmented Reality Guide: A Prospective, Randomized Pilot Trial

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Meong Hi Son, MD, Department of Pediatrics Samsung Medical Center and Sungkyunkwan University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2022

Primary Completion (Actual)

January 28, 2022

Study Completion (Actual)

January 28, 2022

Study Registration Dates

First Submitted

June 25, 2022

First Submitted That Met QC Criteria

June 30, 2022

First Posted (Actual)

July 7, 2022

Study Record Updates

Last Update Posted (Actual)

July 7, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

June 1, 2022

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

No

Studies a U.S. FDA-regulated device product

No

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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