NCT03681301

Brief Summary

The medical school educates students on essential skills, which is an important task. Especially, endotracheal intubation is considered an important option in the management of cardiopulmonary resuscitation. 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 may optimize learning by providing an ethical, cost-effective and more realistic modality to acquire the basic skills of intubation. If it is proven to be effective, efforts to integrate virtual reality technology into routine training of such procedures in the medical school should be promoted. The investigators 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 endotracheal intubation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

September 20, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

August 3, 2019

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

28 days

First QC Date

September 20, 2018

Last Update Submit

December 27, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total score of required 20-key points of intubation during endotracheal intubation procedure

    During the intubation training evaluation using manikin, the score was added by using the check list Which is consisted of the patient's positioning, opening the mouth, laryngoscope handling, glottis view evaluation, insertion and fixation of the endotracheal tube, etc, and consists of a total of 20 points

    within 1 month after training session

Secondary Outcomes (3)

  • Intubation complete time (secs)

    within 1 months after training session

  • Overall proficiency grading (fail/ pass/ high pass/ honors)

    within 1 months after training session

  • Overall confidence, anxiety, comfort level: 5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high)

    within 1 months after training session

Study Arms (2)

Interventional

EXPERIMENTAL

Additional self-directed learning and practice using virtual reality simulator, after conventional training session

Other: virtual reality simulator

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

Additional self-directed learning and practice using virtual reality simulator

Also known as: virtual reality simulator for endotracheal intubation
Interventional

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Participants included medical school students without intubation intubation experience

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double (Investigator, Outcomes Assessor)
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2018

First Posted

September 24, 2018

Study Start

August 3, 2019

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Locations