NCT03685968

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2015

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
3 months until next milestone

Results Posted

Study results publicly available

January 4, 2019

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

2.7 years

First QC Date

September 24, 2018

Results QC Date

November 7, 2018

Last Update Submit

January 4, 2019

Conditions

Airway Management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • First-attempt Successful Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL

    During laryngoscopy and endotracheal tube placement

Other Outcomes (1)

  • Final Intubation Time for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL

    During laryngoscopy and endotracheal tube placement

Study Arms (3)

Glidescope AVL

EXPERIMENTAL
Device: Video laryngoscopes

King Vision Channeled VL

EXPERIMENTAL
Device: Video laryngoscopes

King Vision Non-Channeled (Standard) VL

EXPERIMENTAL
Device: Video laryngoscopes

Interventions

Video laryngoscopesDEVICE

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.

Glidescope AVLKing Vision Channeled VLKing Vision Non-Channeled (Standard) VL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

Results Point of Contact

Title
Elizabeth M. Gendel
Organization
The University of Texas Health Science Center at Houston (UTHealth)
Elizabeth.M.Gendel@uth.tmc.edu
+1 (713) 500-3587

Study Officials

  • Carin A Hagberg, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Academic Officer and Division Head of Anesthesiology, Critical Care, and Pain Medicine

Study Record Dates

First Submitted

September 24, 2018

First Posted

September 26, 2018

Study Start

March 6, 2013

Primary Completion

November 17, 2015

Study Completion

December 17, 2015

Last Updated

January 8, 2019

Results First Posted

January 4, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share