- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06529276
Augmented Reality Smart Glasses Technology for Immersive Learning in the Emergency Department (AGILE1)
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- Accident and Emergency Department, Queen Mary Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Year 5 or 6 medical students during the Emergency Medicine Specialty Clerkship
Exclusion Criteria:
- refusal to consent
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: 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.
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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.
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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
Sponsor
Investigators
- Principal Investigator: Rex Pui Kin Lam, MBBS, FHKCEM, Rex Pui Kin Lam
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGILE1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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