Medical EducationNCT03681301
Development and Impact Assessment of Virtual Reality Simulator on the Education of the Endotracheal Intubation in the Medical Students
A study testing virtual reality simulator in people with Medical Education, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Medical Education
- What is being tested?
- virtual reality simulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Aug 2019to 31 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Participants included medical school students without intubation intubation experience
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 03722
About this study
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.
Read more
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.
- Conditions
- Medical Education
- Being tested
- virtual reality simulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality simulatorOther
Also called virtual reality simulator for endotracheal intubation
Additional self-directed learning and practice using virtual reality simulator
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Additional self-directed learning and practice using virtual reality simulator, after conventional training session Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 1 month after training session
Secondary outcomes (3)
Intubation complete time (secs)
Impact assessment of virtual reality simulator for endotracheal intubation
Measured: within 1 months after training session
Overall proficiency grading (fail/ pass/ high pass/ honors)
Impact assessment of virtual reality simulator for endotracheal intubation
Measured: 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)
Impact assessment of virtual reality simulator for endotracheal intubation
Measured: within 1 months after training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start3 Aug 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Why it stopped: Early Terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EducationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681301
- Sponsor's protocol ID
- 4-2018-0571
- Status last verified
- Dec 2019
- First submitted
- 20 Sep 2018
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Impact Assessment of Virtual Reality Simulator on the Education of the Endotracheal Intubation in the Medical Students
- ClinicalTrials.gov ID
- NCT03681301
- Acronym / sponsor ID
- 4-2018-0571
- Conditions
- Medical Education
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early Terminated
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 3 Aug 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 24 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Other: virtual reality simulatorAdditional self-directed learning and practice using virtual reality simulator, 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
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| virtual reality simulatorAlso: virtual reality simulator for endotracheal intubationAdditional self-directed learning and practice using virtual reality simulator | Other | Interventional |
Primary outcome
Total score of required 20-key points of intubation during endotracheal intubation procedure
Time frame: within 1 month after training session
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
3 secondary outcomes
Intubation complete time (secs)
Time frame: within 1 months after training session
Overall proficiency grading (fail/ pass/ high pass/ honors)
Time frame: 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)
Time frame: within 1 months after training session
Results and safety
The study was stopped early (reason given: Early Terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality simulator in people with Medical Education, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 2 Jan 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 South Korea. 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 was stopped early (reason given: Early Terminated). Results are not available in the source record.
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?
Total score of required 20-key points of intubation during endotracheal intubation procedure (time frame: within 1 month after training session). 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 2 Jan 2020.