- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03663296
Assessing Usefulness of Virtual Reality Mobile Application in Flexible Videoscope Airway Training (AURA)
Assessing Usefulness of Virtual Reality Mobile Application in Flexible Videoscope Airway Training - a Randomised Controlled Trial
Flexible videoscope orotracheal intubation (FOI) technique is considered an important option in the management of predicted difficult airways. However, it is rarely performed in daily practice. Yet emergency physicians are expected to be able to perform this skill expertly during a crisis scenario. If it is not completed in a timely and proper fashion, the patient will deteriorate rapidly, resulting in morbidity or fatality.
There is a significant learning curve to master this complex psychomotor skill. Providing sufficient training in FOI, particularly hands-on experience in real patients is difficult. Patients with known difficult airway requiring FOI present infrequently to the emergency room. Using patients with normal airway purely for teaching of FOI is ethically controversial. To avoid technical and ethical concerns of training involving real patients, conventional teaching methods incorporate the use of a low-fidelity manikin in replacement. However, the manikin anatomy often lacks the realism of a live human.
The addition of virtual reality technology, in the form of a low-cost mobile application (Airway Ex) into the conventional simulation, may optimize learning by providing an ethical, cost-effective and more realistic modality to acquire the basic skills of FOI. If it is proven to be effective, efforts to integrate virtual reality technology into routine training of such procedures in the ED should be promoted.
We hypothesize that the addition of virtual reality mobile application to conventional training will improve procedural skill dexterity and proficiency and hence, improve learner's satisfaction and confidence in performing FOI.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore, 119074
- National University Hospital, Singapore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All doctors from Accidental & Emergency Department of National University Hospital, Singapore
Exclusion Criteria:
- Refusal for consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interventional
Additional 30 minutes of self-directed learning and practice using the mobile application, after conventional training session
|
30 minutes of self-directed learning and practice using the mobile application
|
|
No Intervention: Control
Conventional training session which includes didactic teaching and low-fidelity simulation session involving trainer's demonstration, followed by hands-on practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time taken for successful intubation
Time Frame: 5 minutes
|
time from advancing scope from manikin's mouth to confirmed placement of endotracheal tube through visualisation with videoscope
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time taken for visualisation of vocal cords
Time Frame: 1 minute
|
time from advancing scope from manikin's mouth to first visualisation of vocal cords with videoscope
|
1 minute
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of flexible videoscope manipulation ability
Time Frame: 5 minutes
|
By blinded assessor using validated Five-point Global Rating Scale of Fiberoptic Bronchoscope Manipulation Ability.
Score of 1 indicates very poor techniques whereas a score of 5 indicates clearly superior techniques.
|
5 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ying Wei Yau, National University Hospital, Singapore
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
Other Study ID Numbers
- AURA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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