Intubation; DifficultEMMVLNCT02051400
Evaluation of McGrath® MAC Video Laryngoscope
A study testing the McGrath® MAC video laryngoscope, the GlidesScope® Ranger video laryngoscope and the Macintosh laryngoscope in people with Intubation; Difficult, run by Hanyang University at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate whether the McGrath® MAC video laryngoscope is equal or superior when compared to the Glidescope® Ranger and the Macintosh laryngoscope for novice users in a simulated airway manikin. Read more about this study
- Who is it for?
- Ages 22 to 33 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult
- What is being tested?
- the McGrath® MAC video laryngoscope, the GlidesScope® Ranger video laryngoscope and the Macintosh laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Nov 2013
- 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 22 to 33 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medical students without previous experience of intubation
Who cannot join
- Heart, wrist, or low back disease or who were pregnant were excluded
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hanyang University Guri Hospital
Guri-si, Kyeonggi-do, 471-701
About this study
Official title: Evaluation of McGrath® MAC Using Glidescope® Ranger for Novice Providers in a Simulated Difficult Airway: A Randomised Manikin Study
The purpose of this study is to evaluate whether the McGrath® MAC video laryngoscope is equal or superior when compared to the Glidescope® Ranger and the Macintosh laryngoscope for novice users in a simulated airway manikin.
Read the detailed description
Investigators compared two portable video laryngoscopes (the GlidesScope® Ranger (Verathon Inc, Bothell, WA, USA) and the McGrath® MAC (Aircraft Medical Ltd, Edinburgh, UK)) and a German type Macintosh metal blade with a fiberoptic light. A blade size of 4 was used on all devices. All intubations using video laryngoscopes were performed according to the manufacturers' instructions. A specialised rigid stylet (the GlideRite®) was used with the Glidescope® and a flexible plastic stylet bent with a hockey stick curvature, was used with the McGrath® MAC and the Macintosh laryngoscope. A size 7.5 endotracheal tube (Mallinckrodt™ Hi-Lo Oral/Nasal Tracheal Tube Cuffed Murphy Eye, Covidien, Ireland) was used with all the laryngoscopes.
All participants were randomly divided into 3 device groups. Each group was allowed to attempt to perform endotracheal intubation five more times using the Laerdal® Airway Management Trainer (Laerdal Medical Korea Ltd., Seoul, Korea) with the normal airway setting. After completing the normal airway session, the participants performed another five attempts with the neck immobilisation setting using a neck collar.
The sequence in which the three devices were used was randomly assigned, and all participants performed the same sequence at intervals of five weeks during the study.
- Conditions
- Intubation; Difficult
- Being tested
- the McGrath® MAC video laryngoscope, the GlidesScope® Ranger video laryngoscope, the Macintosh laryngoscope
- Keywords
- Intubation, Laryngoscopes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the McGrath® MAC video laryngoscopeDevice
the GlidesScope® Ranger video laryngoscopeDevice
the Macintosh laryngoscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| Intubation with the McGrath® MAC video laryngoscope | Experimental | Participants perform five intubation attempts using the airway manikin with the normal airway setting. After completing the normal airway session, the participants performed another five attempts with the neck immobilization setting using a neck collar. Receives: Device: the McGrath® MAC video laryngoscope; Device: the GlidesScope® Ranger video laryngoscope; Device: the Macintosh laryngoscope |
| Intubation with the GlidesScope® Ranger video laryngoscope | Experimental | Participants perform five intubation attempts using the airway manikin with the normal airway setting. After completing the normal airway session, the participants performed another five attempts with the neck immobilization setting using a neck collar. Receives: Device: the McGrath® MAC video laryngoscope; Device: the GlidesScope® Ranger video laryngoscope; Device: the Macintosh laryngoscope |
| Intubation with Macintosh laryngoscope | Experimental | Participants perform five intubation attempts using the airway manikin with the normal airway setting. After completing the normal airway session, the participants performed another five attempts with the neck immobilization setting using a neck collar. Receives: Device: the McGrath® MAC video laryngoscope; Device: the GlidesScope® Ranger video laryngoscope; Device: the Macintosh laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation parameter
- The rate for successful intubation
- Time to intubation
- The Cormack-Lehane grade at laryngoscopy
Measured: 1st intubation attempt, an expected average of 1 min
Intubation parameter
- The rate for successful intubation
- Time to intubation
- The Cormack-Lehane grade at laryngoscopy
Measured: 2nd intubation attempt, an expected average of 1 min
Intubation parameter
- The rate for successful intubation
- Time to intubation
- The Cormack-Lehane grade at laryngoscopy
Measured: 3rd intubation attempt, an expected average of 1 min
Intubation parameter
- The rate for successful intubation
- Time to intubation
- The Cormack-Lehane grade at laryngoscopy
Measured: 4th intubation attempt, an expected average of 1 min
Intubation parameter
- The rate for successful intubation
- Time to intubation
- The Cormack-Lehane grade at laryngoscopy
Measured: 5th intubation attempt, an expected average of 1 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation; DifficultStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wonhee Kim, Hanyang University
- Investigators
- Hyuk Joong Choi, MD, PhD, Study director, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051400
- Sponsor's protocol ID
- McGrath® MAC 1
- Acronym
- EMMVL
- Status last verified
- Jan 2014
- First submitted
- 28 Jan 2014
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim W, Choi HJ, Lim T, Kang BS. Can the new McGrath laryngoscope rival the GlideScope Ranger portable video laryngoscope? A randomized manikin study. Am J Emerg Med. 2014 Oct;32(10):1225-9. doi: 10.1016/j.ajem.2014.07.034. Epub 2014 Aug 2.
PubMed 25171799
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of McGrath® MAC Using Glidescope® Ranger for Novice Providers in a Simulated Difficult Airway: A Randomised Manikin Study
- ClinicalTrials.gov ID
- NCT02051400
- Acronym / sponsor ID
- EMMVL / McGrath® MAC 1
- Conditions
- Intubation; Difficult
- Keywords
- Intubation, Laryngoscopes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 31 Jan 2014 (estimated)
- 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 purpose of this study is to evaluate whether the McGrath® MAC video laryngoscope is equal or superior when compared to the Glidescope® Ranger and the Macintosh laryngoscope for novice users in a simulated airway manikin.
Detailed description
Investigators compared two portable video laryngoscopes (the GlidesScope® Ranger (Verathon Inc, Bothell, WA, USA) and the McGrath® MAC (Aircraft Medical Ltd, Edinburgh, UK)) and a German type Macintosh metal blade with a fiberoptic light. A blade size of 4 was used on all devices. All intubations using video laryngoscopes were performed according to the manufacturers' instructions. A specialised rigid stylet (the GlideRite®) was used with the Glidescope® and a flexible plastic stylet bent with a hockey stick curvature, was used with the McGrath® MAC and the Macintosh laryngoscope. A size 7.5 endotracheal tube (Mallinckrodt™ Hi-Lo Oral/Nasal Tracheal Tube Cuffed Murphy Eye, Covidien, Ireland) was used with all the laryngoscopes.
All participants were randomly divided into 3 device groups. Each group was allowed to attempt to perform endotracheal intubation five more times using the Laerdal® Airway Management Trainer (Laerdal Medical Korea Ltd., Seoul, Korea) with the normal airway setting. After completing the normal airway session, the participants performed another five attempts with the neck immobilisation setting using a neck collar.
The sequence in which the three devices were used was randomly assigned, and all participants performed the same sequence at intervals of five weeks during the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intubation with the McGrath® MAC video laryngoscope | Experimental | Device: the McGrath® MAC video laryngoscope, Device: the GlidesScope® Ranger video laryngoscope, Device: the Macintosh laryngoscopeParticipants perform five intubation attempts using the airway manikin with the normal airway setting. After completing the normal airway session, the participants performed another five attempts with the neck immobilization setting using a neck collar. |
| Intubation with the GlidesScope® Ranger video laryngoscope | Experimental | Device: the McGrath® MAC video laryngoscope, Device: the GlidesScope® Ranger video laryngoscope, Device: the Macintosh laryngoscopeParticipants perform five intubation attempts using the airway manikin with the normal airway setting. After completing the normal airway session, the participants performed another five attempts with the neck immobilization setting using a neck collar. |
| Intubation with Macintosh laryngoscope | Experimental | Device: the McGrath® MAC video laryngoscope, Device: the GlidesScope® Ranger video laryngoscope, Device: the Macintosh laryngoscopeParticipants perform five intubation attempts using the airway manikin with the normal airway setting. After completing the normal airway session, the participants performed another five attempts with the neck immobilization setting using a neck collar. |
Who may qualify
- Ages
- 22 to 33 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Medical students without previous experience of intubation
Key exclusion criteria (1 listed)
- Heart, wrist, or low back disease or who were pregnant were excluded
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 |
|---|---|---|
| the McGrath® MAC video laryngoscope | Device | Intubation with Macintosh laryngoscope, Intubation with the GlidesScope® Ranger video laryngoscope, Intubation with the McGrath® MAC video laryngoscope |
| the GlidesScope® Ranger video laryngoscope | Device | Intubation with Macintosh laryngoscope, Intubation with the GlidesScope® Ranger video laryngoscope, Intubation with the McGrath® MAC video laryngoscope |
| the Macintosh laryngoscope | Device | Intubation with Macintosh laryngoscope, Intubation with the GlidesScope® Ranger video laryngoscope, Intubation with the McGrath® MAC video laryngoscope |
Primary outcome
Intubation parameter
Time frame: 1st intubation attempt, an expected average of 1 min
1. The rate for successful intubation 2. Time to intubation 3. The Cormack-Lehane grade at laryngoscopy
Intubation parameter
Time frame: 2nd intubation attempt, an expected average of 1 min
1. The rate for successful intubation 2. Time to intubation 3. The Cormack-Lehane grade at laryngoscopy
Intubation parameter
Time frame: 3rd intubation attempt, an expected average of 1 min
1. The rate for successful intubation 2. Time to intubation 3. The Cormack-Lehane grade at laryngoscopy
Intubation parameter
Time frame: 4th intubation attempt, an expected average of 1 min
1. The rate for successful intubation 2. Time to intubation 3. The Cormack-Lehane grade at laryngoscopy
Intubation parameter
Time frame: 5th intubation attempt, an expected average of 1 min
1. The rate for successful intubation 2. Time to intubation 3. The Cormack-Lehane grade at laryngoscopy
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 31 Jan 2014.
- Derived from this study: PubMed 25171799Kim W, Choi HJ, Lim T, Kang BS. Can the new McGrath laryngoscope rival the GlideScope Ranger portable video laryngoscope? A randomized manikin study. Am J Emerg Med. 2014 Oct;32(10):1225-9. doi: 10.1016/j.ajem.2014.07.034. Epub 2014 Aug 2.
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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.
Hyuk Joong Choi, MD, PhD study director
Hanyang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the McGrath® MAC video laryngoscope, the GlidesScope® Ranger video laryngoscope and the Macintosh laryngoscope in people with Intubation; Difficult, run by Hanyang 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?
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 31 Jan 2014. 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 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?
Intubation parameter (time frame: 1st intubation attempt, an expected average of 1 min). The study lists 5 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 NCT02051400, 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 31 Jan 2014.