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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Airway Management
Intervention Device: Video laryngoscopes
Enrollment 225
Recruitment Details Patients were enrolled from the adult surgical operating rooms of 2 academic hospitals, Lyndon Baines Johnson General Hospital and Memorial Hermann Hospital — Texas Medical Center, in Houston, TX from August 2013 to December 2015.
Pre-assignment Details  
Arm/Group Title Glidescope AVL King Vision Channeled VL King Vision Non-Channeled (Standard) VL
Hide Arm/Group Description Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL. Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL. Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade.
Period Title: Overall Study
Started 75 75 75
Completed 75 75 75
Not Completed 0 0 0
Arm/Group Title Glidescope AVL King Vision Channeled VL King Vision Non-Channeled (Standard) VL Total
Hide Arm/Group Description Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL. Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL. Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade. Total of all reporting groups
Overall Number of Baseline Participants 75 75 75 225
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 75 participants 225 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
68
  90.7%
63
  84.0%
65
  86.7%
196
  87.1%
>=65 years
7
   9.3%
12
  16.0%
10
  13.3%
29
  12.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 75 participants 75 participants 225 participants
48.1  (11.8) 48.0  (15.2) 50.0  (14.2) 48.7  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 75 participants 225 participants
Female
39
  52.0%
41
  54.7%
40
  53.3%
120
  53.3%
Male
36
  48.0%
34
  45.3%
35
  46.7%
105
  46.7%
Height (in)  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 75 participants 75 participants 75 participants 225 participants
66.7  (4.2) 66.4  (4.3) 66.4  (4.2) 66.5  (4.2)
Weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 75 participants 75 participants 75 participants 225 participants
117.5  (20.3) 116.2  (25.5) 116.8  (21.5) 116.8  (22.4)
BMI (kg/m2)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per meter square
Number Analyzed 75 participants 75 participants 75 participants 225 participants
41.2  (8.1) 41.4  (9.9) 41.1  (8.5) 41.2  (8.8)
Neck Circumference (cm)  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 75 participants 75 participants 75 participants 225 participants
47.1  (4.3) 47.1  (4.7) 47.9  (4.3) 47.3  (4.4)
Interincisor distance (cm)  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 75 participants 75 participants 75 participants 225 participants
4.1  (1.0) 4.1  (0.9) 4.1  (1.0) 4.1  (0.9)
Thyromental distance (cm)  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 75 participants 75 participants 75 participants 225 participants
6.8  (1.7) 6.8  (1.9) 7.1  (1.7) 6.9  (1.7)
Sternomental distance (cm)  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 75 participants 75 participants 75 participants 225 participants
13.4  (2.3) 13.6  (2.3) 13.7  (2.1) 13.5  (2.2)
1.Primary Outcome
Title Overall Successful Tracheal Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL
Hide Description The overall intubation success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL
Time Frame During laryngoscopy and endotracheal tube placement
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glidescope AVL King Vision Channeled VL King Vision Non-Channeled (Standard) VL
Hide Arm/Group Description:
Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL.
Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL.
Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade.
Overall Number of Participants Analyzed 75 75 75
Measure Type: Count of Participants
Unit of Measure: Participants
72
  96.0%
61
  81.3%
72
  96.0%
2.Secondary Outcome
Title First-attempt Successful Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL
Hide Description The overall first-attempt success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL
Time Frame During laryngoscopy and endotracheal tube placement
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glidescope AVL King Vision Channeled VL King Vision Non-Channeled (Standard) VL
Hide Arm/Group Description:
Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL.
Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL.
Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade.
Overall Number of Participants Analyzed 75 75 75
Measure Type: Count of Participants
Unit of Measure: Participants
64
  85.3%
53
  70.7%
67
  89.3%
3.Other Pre-specified Outcome
Title Final Intubation Time for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL
Hide Description Total time for placing the endotracheal tube (ETT) through the vocal cords
Time Frame During laryngoscopy and endotracheal tube placement
Hide Outcome Measure Data
Hide Analysis Population Description

Group A: 3 participants excluded due to protocol deviations. Group B: 8 participants excluded due to protocol deviations, 2 participant had failed intubation, 4 participants had device failure.

Group C: 2 participants excluded due to protocol deviations, 1 participant had device failure.

Arm/Group Title Glidescope AVL King Vision Channeled VL King Vision Non-Channeled (Standard) VL
Hide Arm/Group Description:
Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL.
Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL.
Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade.
Overall Number of Participants Analyzed 72 61 72
Mean (Standard Deviation)
Unit of Measure: seconds
46.1  (27.4) 44.9  (21.5) 47.0  (24.3)
Time Frame Postoperatively in the PACU
Adverse Event Reporting Description

(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up.

Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up.

Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.

 
Arm/Group Title Glidescope AVL King Vision Channeled VL King Vision Non-Channeled (Standard) VL
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Glidescope AVL King Vision Channeled VL King Vision Non-Channeled (Standard) VL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)   0/75 (0.00%)   0/75 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Glidescope AVL King Vision Channeled VL King Vision Non-Channeled (Standard) VL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)   0/75 (0.00%)   0/75 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Glidescope AVL King Vision Channeled VL King Vision Non-Channeled (Standard) VL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   26/64 (40.63%)   23/65 (35.38%)   22/70 (31.43%) 
General disorders       
Hoarseness  [1]  26/64 (40.63%)  23/65 (35.38%)  22/70 (31.43%) 
Sore Mouth  [2]  9/64 (14.06%)  5/65 (7.69%)  7/70 (10.00%) 
Sore neck  [3]  9/64 (14.06%)  4/65 (6.15%)  7/70 (10.00%) 
Sore jaw  [4]  4/64 (6.25%)  1/65 (1.54%)  2/70 (2.86%) 
Dysphonia  [5]  7/64 (10.94%)  3/65 (4.62%)  5/70 (7.14%) 
Dysphagia  [6]  13/64 (20.31%)  14/65 (21.54%)  9/70 (12.86%) 
Alteration of tongue  [7]  2/64 (3.13%)  0/65 (0.00%)  2/70 (2.86%) 
Indicates events were collected by systematic assessment
[1]
Hoarseness in voice postoperatively
[2]
Sore Mouth postoperatively
[3]
Sore neck postoperatively
[4]
Sore jaw postoperatively
[5]
Dysphonia postoperatively
[6]
Dysphagia postoperatively
[7]
Alteration of tongue postoperatively
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Elizabeth M. Gendel
Organization: The University of Texas Health Science Center at Houston (UTHealth)
Phone: +1 (713) 500-3587
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.
Responsible Party: Carin A. Hagberg, M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03685968     History of Changes
Other Study ID Numbers: HSC-MS-13-0024
First Submitted: September 24, 2018
First Posted: September 26, 2018
Results First Submitted: November 7, 2018
Results First Posted: January 4, 2019
Last Update Posted: January 8, 2019