NCT03663296

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

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 24, 2018

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 2, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2019

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

18 days

First QC Date

September 2, 2018

Last Update Submit

March 11, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time taken for successful intubation

    time from advancing scope from manikin's mouth to confirmed placement of endotracheal tube through visualisation with videoscope

    5 minutes

Secondary Outcomes (1)

  • Time taken for visualisation of vocal cords

    1 minute

Other Outcomes (1)

  • Quality of flexible videoscope manipulation ability

    5 minutes

Study Arms (2)

Interventional

EXPERIMENTAL

Additional 30 minutes of self-directed learning and practice using the mobile application, after conventional training session

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

Interventions

30 minutes of self-directed learning and practice using the mobile application

Interventional

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All doctors from Accidental \& Emergency Department of National University Hospital, Singapore

You may not qualify if:

  • Refusal for consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital, Singapore

Singapore, 119074, Singapore

Location

Study Officials

  • Ying Wei Yau

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2018

First Posted

September 10, 2018

Study Start

July 24, 2018

Primary Completion

August 11, 2018

Study Completion

August 11, 2019

Last Updated

March 13, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations