NCT06529276

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

18 days

First QC Date

July 19, 2024

Last Update Submit

July 30, 2024

Conditions

Keywords

Augmented realitySmart glassesEmergency airway managementLearningEmergency department

Outcome Measures

Primary Outcomes (1)

  • 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

    Immediately after the AR/control learning session

Secondary Outcomes (6)

  • Student domain interest

    Immediately after the AR/control learning session

  • Student opinion on the learning method

    Immediately after the AR/control learning session

  • Student perceived motivation

    Immediately after the AR/control learning session

  • Self-efficacy

    Immediately after the AR/control learning session

  • Student cognitive load

    Immediately after the AR/control learning session

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Other: Control arm regular clinical learning

Interventions

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.

Augmented reality (AR) clinical learning arm

Regular bedside learning of emergency airway management including endotracheal intubation using video laryngoscope and other AGPs, such as bag-valve-mask ventilation,

Control clinical learning arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • refusal to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Accident and Emergency Department, Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rex Pui Kin Lam, MBBS, FHKCEM

    Rex Pui Kin Lam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor of Emergency Medicine

Study Record Dates

First Submitted

July 19, 2024

First Posted

July 31, 2024

Study Start

July 1, 2024

Primary Completion

July 19, 2024

Study Completion

July 19, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

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

Locations