King Vision® and GlideScope® in Difficult Airways

A Comparison of the King Vision® Channeled, King Vision® Non-Channeled, and Glidescope® Video Intubation Systems in Patients at Risk for Difficult Intubation - A Pilot Study

There are several advantages of video laryngoscopy; especially their ability to provide superior glottis visualization, as compared to traditional laryngoscopy.1-3 The purpose of this three arm study was to compare the safety and efficacy of the King Vision® Video Intubation Systems (AMBU-King Systems, Denmark) to the Cobalt GlideScope® (Verathon Medical Inc., USA) in patients with anticipated difficult airways.

Study Overview

• Status: Completed
• Conditions: Airway Management
• Intervention / Treatment: Device: Video laryngoscopes

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Over 18 years of age
• Mallampati III-IV
• Neck circumference > 43cm
• Reduced mouth opening (< 4cm) or 3 Finger breath's (patient's own)
• Thyromental distance < 6cm

Exclusion Criteria:

• Mallampati I-II
• Neck circumference < 43cm
• Documented 'easy' intubation
• Previous history of failed intubation and failed bag-mask ventilation
• Under 18 years of age
• ASA IV
• Known unstable cervical spine injury
• Presentation for an emergency surgical procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glidescope AVL	Device: Video laryngoscopes; Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT.
Experimental: King Vision Channeled VL	Device: Video laryngoscopes; Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT.
Experimental: King Vision Non-Channeled (Standard) VL	Device: Video laryngoscopes; Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Successful Tracheal Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL	The overall intubation success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL	During laryngoscopy and endotracheal tube placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First-attempt Successful Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL	The overall first-attempt success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL	During laryngoscopy and endotracheal tube placement

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Final Intubation Time for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL	Total time for placing the endotracheal tube (ETT) through the vocal cords	During laryngoscopy and endotracheal tube placement

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: King Systems Corporation
• Investigators: Study Chair: Carin A Hagberg, MD, The University of Texas Md Anderson Cancer Center

Publications and helpful links

General Publications

• Hagberg CA, Iannucci D, Goodrich A. A comparison of the glottic view obtained with the Macintosh Video Laryngoscope in anesthetized, paralyzed, apneic patients. Direct view vs video monitor. Anesthesiology 2003; 103: A1501.
• Hagberg C, Matuszczak M, Ellis S, et al. A randomized comparison of laryngoscopy techniques using the video laryngoscope and the traditional Macintosh laryngoscope in obese patients. Anesthesiology 2005; 103: A1420.
• Hagberg C, Vogt-Harenkamp C, Bogomolny Y, et al. A comparison of laryngoscopy techniques using the video laryngoscope and the traditional Macintosh laryngoscope in potentially difficult to intubate patients. Anesth Analg 2005; 100: S-212.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2013
• Primary Completion (Actual): November 17, 2015
• Study Completion (Actual): December 17, 2015

Study Registration Dates

• First Submitted: September 24, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: January 4, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HSC-MS-13-0024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes