Airway ManagementNCT03471975
Learning Direct Laryngoscopy Using a McGrath Video Laryngoscope as Direct Versus Indirect Laryngoscope
A study testing direct laryngoscope and video laryngoscope in people with Airway Management and Endotracheal Intubation, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
prospective randomised trial to compare the teaching effect for tracheal intubation following training with McGrath video laryngoscope as direct laryngoscope versus training with McGrath video laryngoscope as video laryngoscope Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Airway Management, Endotracheal Intubation, Medical Education
- What is being tested?
- direct laryngoscope and video laryngoscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Mar 2018to 9 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- medical students who has never experienced intubation
Who cannot join
- A person who has previously experienced intubation with Manikin or patients.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou University School of Medicine
Suwon, Gyeonggi-do, 16499
About this study
Official title: Comparison of Training Effect for Tracheal Intubation Following Training With McGrath Video Laryngoscope as Direct Laryngoscope Versus Training With McGrath Video Laryngoscope as Video Laryngoscope
prospective randomised trial to compare the teaching effect for tracheal intubation following training with McGrath video laryngoscope as direct laryngoscope versus training with McGrath video laryngoscope as video laryngoscope
Read the detailed description
Tracheal intubation using direct laryngoscopy is very important technique in clinical medicine. But the training for intubation is not very easy because laryngoscopic view is difficult to share between trainee and trainer.
Recently there have been reported that tracheal intubation training using video laryngoscopy have some advantages and showed more success rate.
McGrath Video laryngoscopy can be used as either video laryngoscopy or direct laryngoscopy. Therefore when McGrath is used as intubation training tool, the trainer can monitor and educate the procedure while the trainee perform tracheal intubation.
The aim of this study is comparing the teaching effect for tracheal intubation following training with McGrath video laryngoscope as direct laryngoscope versus training with McGrath video laryngoscope as video laryngoscope
- Being tested
- direct laryngoscope, video laryngoscope
- Keywords
- Video laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct laryngoscopeProcedure or surgery
the trainee use McGrath video laryngoscope as direct laryngoscope the trainee is not allowed to watch the screen.
video laryngoscopeProcedure or surgery
the trainee use McGrath video laryngoscope both trainee and trainer can watch the screen.
| Study group | Role | What they receive |
|---|---|---|
| direct laryngoscope | Active comparator | teaching tracheal intubation using McGrath video laryngoscope as direct laryngoscope. Only trainer can see the monitor. Receives: Procedure: direct laryngoscope |
| video laryngoscope | Active comparator | teaching tracheal intubation using McGrath video laryngoscope using video function.
Trainer and Trainee both see the monitor. Receives: Procedure: video laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation Success Rate
tracheal intubation success rate using direct laryngoscope on manikin
Measured: up to 10 minutes
Time to Intubation
Time from device passing the mouth until confirmation of tracheal intubation
Measured: up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start12 Mar 2018
- Primary completion9 Jul 2018
- Study completion9 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jihoon Hwang, MD, Ajou University School of Medicine
- Investigators
- Jihoon Hwang, MD, Principal investigator, Clinical Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471975
- Sponsor's protocol ID
- AJIRB-SBR-OBS-17-507
- Status last verified
- Jul 2019
- First submitted
- 9 Mar 2018
- Last updated
- 19 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yi IK, Hwang J, Min SK, Lim GM, Chae YJ. Comparison of learning direct laryngoscopy using a McGrath videolaryngoscope as a direct versus indirect laryngoscope: a randomized controlled trial. J Int Med Res. 2021 May;49(5):3000605211016740. doi: 10.1177/03000605211016740.
PubMed 34024186
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Training Effect for Tracheal Intubation Following Training With McGrath Video Laryngoscope as Direct Laryngoscope Versus Training With McGrath Video Laryngoscope as Video Laryngoscope
- ClinicalTrials.gov ID
- NCT03471975
- Acronym / sponsor ID
- AJIRB-SBR-OBS-17-507
- Keywords
- Video laryngoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 9 Jul 2018 (actual)
- Study completion
- 9 Jul 2018 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Posted 19 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
prospective randomised trial to compare the teaching effect for tracheal intubation following training with McGrath video laryngoscope as direct laryngoscope versus training with McGrath video laryngoscope as video laryngoscope
Detailed description
Tracheal intubation using direct laryngoscopy is very important technique in clinical medicine. But the training for intubation is not very easy because laryngoscopic view is difficult to share between trainee and trainer.
Recently there have been reported that tracheal intubation training using video laryngoscopy have some advantages and showed more success rate.
McGrath Video laryngoscopy can be used as either video laryngoscopy or direct laryngoscopy. Therefore when McGrath is used as intubation training tool, the trainer can monitor and educate the procedure while the trainee perform tracheal intubation.
The aim of this study is comparing the teaching effect for tracheal intubation following training with McGrath video laryngoscope as direct laryngoscope versus training with McGrath video laryngoscope as video laryngoscope
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| direct laryngoscope | Active comparator | Procedure: direct laryngoscopeteaching tracheal intubation using McGrath video laryngoscope as direct laryngoscope. Only trainer can see the monitor. |
| video laryngoscope | Active comparator | Procedure: video laryngoscopeteaching tracheal intubation using McGrath video laryngoscope using video function. Trainer and Trainee both see the monitor. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- medical students who has never experienced intubation
Key exclusion criteria (1 listed)
- A person who has previously experienced intubation with Manikin or patients.
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 |
|---|---|---|
| direct laryngoscopethe trainee use McGrath video laryngoscope as direct laryngoscope the trainee is not allowed to watch the screen. | Procedure or surgery | direct laryngoscope |
| video laryngoscopethe trainee use McGrath video laryngoscope both trainee and trainer can watch the screen. | Procedure or surgery | video laryngoscope |
Primary outcome
Intubation Success Rate
Time frame: up to 10 minutes
tracheal intubation success rate using direct laryngoscope on manikin
Time to Intubation
Time frame: up to 10 minutes
Time from device passing the mouth until confirmation of tracheal intubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34024186Yi IK, Hwang J, Min SK, Lim GM, Chae YJ. Comparison of learning direct laryngoscopy using a McGrath videolaryngoscope as a direct versus indirect laryngoscope: a randomized controlled trial. J Int Med Res. 2021 May;49(5):3000605211016740. doi: 10.1177/03000605211016740.
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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.
Jihoon Hwang, MD principal investigator
Clinical Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing direct laryngoscope and video laryngoscope in people with Airway Management and Endotracheal Intubation, run by Ajou University School of Medicine 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?
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 19 Aug 2019. 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?
Yes. Results are posted in the registry (first posted 19 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intubation Success Rate (time frame: up to 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03471975, which also lists 1 linked publication.
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 19 Aug 2019.