- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02051400
Evaluation of McGrath® MAC Video Laryngoscope (EMMVL)
Evaluation of McGrath® MAC Using Glidescope® Ranger for Novice Providers in a Simulated Difficult Airway: A Randomised Manikin Study
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kyeonggi-do
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Guri-si, Kyeonggi-do, Korea, Republic of, 471-701
- Hanyang University Guri Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Medical students without previous experience of intubation
Exclusion Criteria:
- Heart, wrist, or low back disease or who were pregnant were excluded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intubation with the McGrath® MAC video laryngoscope
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.
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|
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Experimental: Intubation with the GlidesScope® Ranger video laryngoscope
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.
|
|
|
Experimental: Intubation with Macintosh laryngoscope
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intubation parameter
Time Frame: 1st intubation attempt, an expected average of 1 min
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1st intubation attempt, an expected average of 1 min
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Intubation parameter
Time Frame: 2nd intubation attempt, an expected average of 1 min
|
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2nd intubation attempt, an expected average of 1 min
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Intubation parameter
Time Frame: 3rd intubation attempt, an expected average of 1 min
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3rd intubation attempt, an expected average of 1 min
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Intubation parameter
Time Frame: 4th intubation attempt, an expected average of 1 min
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4th intubation attempt, an expected average of 1 min
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Intubation parameter
Time Frame: 5th intubation attempt, an expected average of 1 min
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5th intubation attempt, an expected average of 1 min
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hyuk Joong Choi, MD, PhD, Hanyang University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- McGrath® MAC 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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