Augmented Reality Smart Glasses Technology for Immersive Learning in the Emergency Department (AGILE1)

July 30, 2024 updated by: Lam Pui Kin, The University of Hong Kong

Augmented Reality Smart Glasses Technology for Immersive Learning in the Emergency Department (AGILE-1): a Pilot Randomised Controlled Study

The COVID-19 pandemic has disrupted traditional clinical teaching, depriving medical students of valuable clinical engagement with patients who required an aerosol-generating procedure (AGP) in the emergency department (ED). Because of the infection control restrictions, medical students are not allowed to enter resuscitation room where AGPs takes place, even in the aftermath of the pandemic.

The Microsoft HoloLens 2 is an augmented reality (AR) head-mounted device (HMD) which enables a single clinical teacher to facilitate real-time distant immersive learning by medical students on critically ill ED patients while insulating them from infection risks. Our team has successfully developed an AR HMD prototype based on HoloLens for clinical teaching and conducted 10 pilot teaching sessions. Overall, the audio-visual quality of the video-laryngoscope image captured by the HoloLens were rated satisfactorily by the students. Cybersickness symptoms such as dizziness, nausea, and eye strain were infrequent among the viewers.

The investigators conduct a pilot randomised controlled trial (RCT) which aims to evaluate the feasibility of conducting a full-scale RCT. The investigators collect data of the impact of AR learning and bedside learning on student knowledge gain, cognitive load, motivation and adverse effects. The investigators invite 33 Year 5 or 6 medical students to participate in this study during the Emergency Medicine Specialty Clerkship rotation at the Accident and Emergency Department (A&E) of Queen Mary Hospital (QMH). Consented medical students are randomly assigned in clusters based on their existing student group assignment (around 10 students per each small group) in a 1:1 to two arms: AR clinical learning arm and the control arm (bedside clinical learning).

Randomisation is performed by a research assistant not directly involved in the study using sequentially numbered opaque, sealed envelopes. Given the first-person perspective through the HoloLens, it is not possible to blind the medical students.

To standardise the teaching content of all study sessions, all such sessions are delivered by the principal investigator (PI) of this study during the study period and the pre-reading materials are the same for both groups. The PI will demonstrate endotracheal intubation using video laryngoscope and other AGPs on a manikin in the resuscitation room.

Study Overview

Study Type

Interventional

Enrollment (Actual)

33

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

      • Hong Kong, Hong Kong
        • Accident and Emergency Department, Queen Mary Hospital

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

No

Description

Inclusion Criteria:

  • Year 5 or 6 medical students during the Emergency Medicine Specialty Clerkship

Exclusion Criteria:

  • refusal to consent

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: Augmented reality (AR) clinical learning arm
In the AR clinical learning arm, students will have one 3-hour session of AR clinical learning of emergency airway management. The PI will put on a HoloLens device and demonstrate endotracheal intubation using video laryngoscope (C-MAC®) and other AGPs, such as bag-valve-mask ventilation on a manikin in the resuscitation room. The students will be situated in another room and have a first-person view captured by the HoloLens during the demonstration.
Clinical learning of emergency airway management including endotracheal intubation using video laryngoscope and other AGPs, such as bag-valve-mask ventilation, using augmented reality immersive learning technology.
Active Comparator: Control clinical learning arm
In the control arm, students will have one 3-hour regular session of bedside learning of emergency airway management. The PI will demonstrate endotracheal intubation using video laryngoscope (C-MAC®) and other AGPs, such as bag-valve-mask ventilation on a manikin in the resuscitation room in front of the students there.
Regular bedside learning of emergency airway management including endotracheal intubation using video laryngoscope and other AGPs, such as bag-valve-mask ventilation,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge gain (in full-scale RCT)
Time Frame: Immediately after the AR/control learning session
Knowledge gain measured with pre- and post-AR/control session knowledge tests, which consist of 20 multiple choice questions on emergency airway management
Immediately after the AR/control learning session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Student domain interest
Time Frame: Immediately after the AR/control learning session
Student interest in emergency airway management assessed with 3 questions (e.g. "I know a lot about emergency airway management.") with responses captured using 100 mm visual analogue scales. To each of these questions, the answer ranges from 0 to 100 on a VAS where 0 is complete disagreement and 100 is perfect agreement with the statement.
Immediately after the AR/control learning session
Student opinion on the learning method
Time Frame: Immediately after the AR/control learning session
Student opinion on the learning method assessed with 5 questions (e.g. "The learning method is highly effective for me to learn about emergency airway management.") with responses captured using 100 mm visual analogue scales. To each of these questions, the answer ranges from 0 to 100 on a VAS where 0 is complete disagreement and 100 is perfect agreement with the statement.
Immediately after the AR/control learning session
Student perceived motivation
Time Frame: Immediately after the AR/control learning session
Student perceived motivation assessed with 4 questions (e.g. "The quality of the clinical session helped to hold my attention.") with responses captured using 100 mm visual analogue scales. To each of these questions, the answer ranges from 0 to 100 on a VAS where 0 is complete disagreement and 100 is perfect agreement with the statement.
Immediately after the AR/control learning session
Self-efficacy
Time Frame: Immediately after the AR/control learning session
Student self-efficacy assessed with 5 questions (e.g."I am confident that I will be able to master the skills taught in this clinical session.") with responses captured using 100 mm visual analogue scales. To each of these questions, the answer ranges from 0 to 100 on a VAS where 0 is complete disagreement and 100 is perfect agreement with the statement.
Immediately after the AR/control learning session
Student cognitive load
Time Frame: Immediately after the AR/control learning session
Student cognitive load assessed with 7 questions (e.g. "For this clinical session, many things needed to be kept in mind simultaneously.") with responses captured using 100 mm visual analogue scales. To each of these questions, the answer ranges from 0 to 100 on a VAS where 0 is complete disagreement and 100 is perfect agreement with the statement.
Immediately after the AR/control learning session
Adverse health effects
Time Frame: Immediately after the AR/control learning session
Adverse health effects during the learning session such as symptoms of cybersickness assessed including dizziness and nausea using 7-point Likert scale, with higher numerical scores indicating more severe symptoms.
Immediately after the AR/control learning session

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Rex Pui Kin Lam, MBBS, FHKCEM, Rex Pui Kin Lam

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)

July 1, 2024

Primary Completion (Actual)

July 19, 2024

Study Completion (Actual)

July 19, 2024

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

July 31, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data could be shared with other researchers upon reasonable requests and after additional approval by the institutional review board.

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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