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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

Tracking Information
First Submitted Date  ICMJE September 24, 2018
First Posted Date  ICMJE September 26, 2018
Results First Submitted Date  ICMJE November 7, 2018
Results First Posted Date  ICMJE January 4, 2019
Last Update Posted Date January 8, 2019
Actual Study Start Date  ICMJE March 6, 2013
Actual Primary Completion Date November 17, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2018)
Successful tracheal intubation-KVChVL versus GSAVL [ Time Frame: 2 years ]
We hypothesize that the King Vision™ Channeled VL is more efficacious in terms of successful tracheal intubation, in comparison to the GlideScope® AVL.
Change History Complete list of historical versions of study NCT03685968 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2018)
Successful tracheal intubation-KVNChVL versus GSAVL [ Time Frame: 2 years ]
It is further hypothesized that the King Vision™ Non-Channeled (Standard) VL is equivalent to the Glidescope® AVL regarding successful tracheal intubations.
Current Other Pre-specified Outcome Measures
 (submitted: December 10, 2018)
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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE King Vision® and GlideScope® in Difficult Airways
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Airway Management
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Glidescope AVL
    Intervention: Device: Video laryngoscopes
  • Experimental: King Vision Channeled VL
    Intervention: Device: Video laryngoscopes
  • Experimental: King Vision Non-Channeled (Standard) VL
    Intervention: Device: Video laryngoscopes
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2018)
225
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 17, 2015
Actual Primary Completion Date November 17, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03685968
Other Study ID Numbers  ICMJE HSC-MS-13-0024
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Carin A. Hagberg, M.D. Anderson Cancer Center
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE King Systems Corporation
Investigators  ICMJE
Study Chair: Carin A Hagberg, MD The University of Texas MD Anderson Cancer Center
PRS Account The University of Texas Health Science Center, Houston
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP