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OpenTrials
Completed

NCT Number: NCT05446896

Effectiveness of AR in Ventilator Setting Education.

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.

Completed

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Centre

Seoul, 06351, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

AR guidance with Hololens 2

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. the required level of assistance

    Time frame: 30 minutes

    The number of steps needed assistance to complete the procedure

Other outcomes

  1. Usability

    Time frame: 30 minutes

    System usability scale

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Acronym: AR

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2022
Registry last updated
Jul 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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