Education, MedicalAURANCT03663296
Assessing Usefulness of Virtual Reality Mobile Application in Flexible Videoscope Airway Training
A study testing Airway Ex App in people with Education, Medical, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Education, Medical
- What is being tested?
- Airway Ex App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSingapore
- Study dates
- 24 Jul 2018to 11 Aug 2019
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All doctors from Accidental \& Emergency Department of National University Hospital, Singapore
Who cannot join
- Refusal for consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Education, Medical
- Being tested
- Airway Ex App
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway Ex AppOther
30 minutes of self-directed learning and practice using the mobile application
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Additional 30 minutes of self-directed learning and practice using the mobile application, after conventional training session Receives: Other: Airway Ex App |
| Control | No intervention | Conventional training session which includes didactic teaching and low-fidelity simulation session involving trainer's demonstration, followed by hands-on practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken for successful intubation
time from advancing scope from manikin's mouth to confirmed placement of endotracheal tube through visualisation with videoscope
Measured: 5 minutes
Secondary outcomes (1)
Time taken for visualisation of vocal cords
time from advancing scope from manikin's mouth to first visualisation of vocal cords with videoscope
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start24 Jul 2018
- Primary completion11 Aug 2018
- Study completion11 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Education, MedicalStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Wei Yau, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663296
- Sponsor's protocol ID
- AURA
- Acronym
- AURA
- Status last verified
- Mar 2020
- First submitted
- 2 Sep 2018
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Usefulness of Virtual Reality Mobile Application in Flexible Videoscope Airway Training - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03663296
- Acronym / sponsor ID
- AURA / AURA
- Conditions
- Education, Medical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 11 Aug 2018 (actual)
- Study completion
- 11 Aug 2019 (actual)
- First posted
- 10 Sep 2018 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Other: Airway Ex AppAdditional 30 minutes of self-directed learning and practice using the mobile application, after conventional training session |
| Control | No intervention | –Conventional training session which includes didactic teaching and low-fidelity simulation session involving trainer's demonstration, followed by hands-on practice |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All doctors from Accidental \& Emergency Department of National University Hospital, Singapore
Key exclusion criteria (1 listed)
- Refusal for 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 |
|---|---|---|
| Airway Ex App30 minutes of self-directed learning and practice using the mobile application | Other | Interventional |
Primary outcome
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
1 secondary outcome
Time taken for visualisation of vocal cords
Time frame: 1 minute
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 13 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Ying Wei Yau principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airway Ex App in people with Education, Medical, run by National University Hospital, Singapore at 1 site in Singapore.
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 13 Mar 2020. 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 Singapore. 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?
Time taken for successful intubation (time frame: 5 minutes). 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 13 Mar 2020.