Evaluation of McGrath® MAC Video Laryngoscope

Intubation; Difficult Clinical Trial

— EMMVL  

Official title:

Evaluation of McGrath® MAC Using Glidescope® Ranger for Novice Providers in a Simulated Difficult Airway: A Randomised Manikin Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02051400
• Other study ID #: McGrath® MAC 1
• Status: Completed
• Phase: N/A
• First received: January 28, 2014
• Last updated: January 30, 2014
• Start date: September 2013
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Hanyang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years to 33 Years

Eligibility

Inclusion Criteria:

• Medical students without previous experience of intubation

Exclusion Criteria:

• Heart, wrist, or low back disease or who were pregnant were excluded

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Intubation; Difficult

Intervention

Device:
• the McGrath® MAC video laryngoscope

• the GlidesScope® Ranger video laryngoscope

• the Macintosh laryngoscope

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Guri Hospital	Guri-si	Kyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation parameter	The rate for successful intubation; Time to intubation; The Cormack-Lehane grade at laryngoscopy	1st intubation attempt, an expected average of 1 min	No
Primary	Intubation parameter	The rate for successful intubation; Time to intubation; The Cormack-Lehane grade at laryngoscopy	2nd intubation attempt, an expected average of 1 min	No
Primary	Intubation parameter	The rate for successful intubation; Time to intubation; The Cormack-Lehane grade at laryngoscopy	3rd intubation attempt, an expected average of 1 min	No
Primary	Intubation parameter	The rate for successful intubation; Time to intubation; The Cormack-Lehane grade at laryngoscopy	4th intubation attempt, an expected average of 1 min	No
Primary	Intubation parameter	The rate for successful intubation; Time to intubation; The Cormack-Lehane grade at laryngoscopy	5th intubation attempt, an expected average of 1 min	No