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King Vision® and GlideScope® in Difficult Airways

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ClinicalTrials.gov Identifier: NCT03685968
Recruitment Status : Completed
First Posted : September 26, 2018
Results First Posted : January 4, 2019
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
King Systems Corporation
Information provided by (Responsible Party):
Carin A. Hagberg, M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Airway Management Device: Video laryngoscopes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 6, 2013
Actual Primary Completion Date : November 17, 2015
Actual Study Completion Date : December 17, 2015

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.




Primary Outcome Measures :
  1. Overall Successful Tracheal Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL [ Time Frame: During laryngoscopy and endotracheal tube placement ]
    The overall intubation success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL


Secondary Outcome Measures :
  1. First-attempt Successful Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL [ Time Frame: During laryngoscopy and endotracheal tube placement ]
    The overall first-attempt success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL


Other Outcome Measures:
  1. Final Intubation Time for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL [ Time Frame: During laryngoscopy and endotracheal tube placement ]
    Total time for placing the endotracheal tube (ETT) through the vocal cords



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685968


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

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.

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Responsible Party: Carin A. Hagberg, Chief Academic Officer and Division Head of Anesthesiology, Critical Care, and Pain Medicine, M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03685968     History of Changes
Other Study ID Numbers: HSC-MS-13-0024
First Posted: September 26, 2018    Key Record Dates
Results First Posted: January 4, 2019
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes