Augmented RealityAGILE1NCT06529276
Augmented Reality Smart Glasses Technology for Immersive Learning in the Emergency Department
A study testing Augmented reality clinical learning in people with Augmented Reality, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Augmented Reality
- What is being tested?
- Augmented reality clinical learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2024to 19 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Year 5 or 6 medical students during the Emergency Medicine Specialty Clerkship
Who cannot join
- refusal to consent
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Accident and Emergency Department, Queen Mary Hospital
Hong Kong
About this study
Official title: 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.
Read more
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.
- Conditions
- Augmented Reality
- Being tested
- Augmented reality clinical learning, Control arm regular clinical learning
- Keywords
- Augmented reality, Smart glasses, Emergency airway management, Learning, Emergency department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented reality clinical learningOther
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.
Control arm regular clinical learningOther
Regular bedside learning of emergency airway management including endotracheal intubation using video laryngoscope and other AGPs, such as bag-valve-mask ventilation,
| Study group | Role | What they receive |
|---|---|---|
| Augmented reality (AR) clinical learning arm | Experimental | 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. Receives: Other: Augmented reality clinical learning |
| Control clinical learning arm | Active comparator | 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. Receives: Other: Control arm regular clinical learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge gain (in full-scale RCT)
Knowledge gain measured with pre- and post-AR/control session knowledge tests, which consist of 20 multiple choice questions on emergency airway management
Measured: Immediately after the AR/control learning session
Secondary outcomes (6)
Student domain interest
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.
Measured: Immediately after the AR/control learning session
Student opinion on the learning method
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.
Measured: Immediately after the AR/control learning session
Student perceived motivation
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.
Measured: Immediately after the AR/control learning session
Self-efficacy
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.
Measured: Immediately after the AR/control learning session
Student cognitive load
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.
Measured: Immediately after the AR/control learning session
Adverse health effects
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.
Measured: Immediately after the AR/control learning session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Jul 2024
- Primary completion19 Jul 2024
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Augmented RealityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lam Pui Kin, The University of Hong Kong
- Investigators
- Rex Pui Kin Lam, MBBS, FHKCEM, Principal investigator, Rex Pui Kin Lam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529276
- Sponsor's protocol ID
- AGILE1
- Acronym
- AGILE1
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data could be shared with other researchers upon reasonable requests and after additional approval by the institutional review board.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Reality Smart Glasses Technology for Immersive Learning in the Emergency Department (AGILE-1): a Pilot Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06529276
- Acronym / sponsor ID
- AGILE1 / AGILE1
- Conditions
- Augmented Reality
- Keywords
- Augmented reality, Smart glasses, Emergency airway management, Learning, Emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmented reality (AR) clinical learning arm | Experimental | Other: Augmented reality clinical learningIn 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. |
| Control clinical learning arm | Active comparator | Other: Control arm regular clinical learningIn 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Year 5 or 6 medical students during the Emergency Medicine Specialty Clerkship
Key exclusion criteria (1 listed)
- refusal to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented reality clinical learningClinical 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. | Other | Augmented reality (AR) clinical learning arm |
| Control arm regular clinical learningRegular bedside learning of emergency airway management including endotracheal intubation using video laryngoscope and other AGPs, such as bag-valve-mask ventilation, | Other | Control clinical learning arm |
Primary outcome
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
6 secondary outcomes
Student domain interest
Time frame: Immediately after the AR/control learning session
Student opinion on the learning method
Time frame: Immediately after the AR/control learning session
Student perceived motivation
Time frame: Immediately after the AR/control learning session
Self-efficacy
Time frame: Immediately after the AR/control learning session
Student cognitive load
Time frame: Immediately after the AR/control learning session
Adverse health effects
Time frame: Immediately after the AR/control learning session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No. Data could be shared with other researchers upon reasonable requests and after additional approval by the institutional review board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rex Pui Kin Lam, MBBS, FHKCEM principal investigator
Rex Pui Kin Lam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented reality clinical learning in people with Augmented Reality, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge gain (in full-scale RCT) (time frame: Immediately after the AR/control learning session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024; AzTrials last refreshed its copy on 30 Oct 2026.