Airway Management
Conditions
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.
Interventions
DEVICEVideo 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.
Sponsors
King Systems Corporation
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Successful Tracheal Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL | During laryngoscopy and endotracheal tube placement | The overall intubation success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First-attempt Successful Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL | During laryngoscopy and endotracheal tube placement | The overall first-attempt success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL |
Other
| Measure | Time frame | Description |
|---|---|---|
| Final Intubation Time for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL | During laryngoscopy and endotracheal tube placement | Total time for placing the endotracheal tube (ETT) through the vocal cords |
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Glidescope AVL 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. | 75 |
| King Vision Channeled VL 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. | 75 |
| King Vision Non-Channeled (Standard) 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. | 75 |
| Total | 225 |
Baseline characteristics
| Characteristic | Glidescope AVL | King Vision Channeled VL | King Vision Non-Channeled (Standard) VL | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 12 Participants | 10 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants | 63 Participants | 65 Participants | 196 Participants |
| Age, Continuous | 48.1 years STANDARD_DEVIATION 11.8 | 48.0 years STANDARD_DEVIATION 15.2 | 50.0 years STANDARD_DEVIATION 14.2 | 48.7 years STANDARD_DEVIATION 13.7 |
| BMI (kg/m2) | 41.2 kilogram per meter square STANDARD_DEVIATION 8.1 | 41.4 kilogram per meter square STANDARD_DEVIATION 9.9 | 41.1 kilogram per meter square STANDARD_DEVIATION 8.5 | 41.2 kilogram per meter square STANDARD_DEVIATION 8.8 |
| Height (in) | 66.7 inches STANDARD_DEVIATION 4.2 | 66.4 inches STANDARD_DEVIATION 4.3 | 66.4 inches STANDARD_DEVIATION 4.2 | 66.5 inches STANDARD_DEVIATION 4.2 |
| Interincisor distance (cm) | 4.1 centimeters STANDARD_DEVIATION 1 | 4.1 centimeters STANDARD_DEVIATION 0.9 | 4.1 centimeters STANDARD_DEVIATION 1 | 4.1 centimeters STANDARD_DEVIATION 0.9 |
| Neck Circumference (cm) | 47.1 centimeters STANDARD_DEVIATION 4.3 | 47.1 centimeters STANDARD_DEVIATION 4.7 | 47.9 centimeters STANDARD_DEVIATION 4.3 | 47.3 centimeters STANDARD_DEVIATION 4.4 |
| Sex: Female, Male Female | 39 Participants | 41 Participants | 40 Participants | 120 Participants |
| Sex: Female, Male Male | 36 Participants | 34 Participants | 35 Participants | 105 Participants |
| Sternomental distance (cm) | 13.4 centimeters STANDARD_DEVIATION 2.3 | 13.6 centimeters STANDARD_DEVIATION 2.3 | 13.7 centimeters STANDARD_DEVIATION 2.1 | 13.5 centimeters STANDARD_DEVIATION 2.2 |
| Thyromental distance (cm) | 6.8 centimeters STANDARD_DEVIATION 1.7 | 6.8 centimeters STANDARD_DEVIATION 1.9 | 7.1 centimeters STANDARD_DEVIATION 1.7 | 6.9 centimeters STANDARD_DEVIATION 1.7 |
| Weight (kg) | 117.5 kilograms STANDARD_DEVIATION 20.3 | 116.2 kilograms STANDARD_DEVIATION 25.5 | 116.8 kilograms STANDARD_DEVIATION 21.5 | 116.8 kilograms STANDARD_DEVIATION 22.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 75 | 0 / 75 |
| other Total, other adverse events | 26 / 64 | 23 / 65 | 22 / 70 |
| serious Total, serious adverse events | 0 / 75 | 0 / 75 | 0 / 75 |
Outcome results
Primary
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
Time frame: During laryngoscopy and endotracheal tube placement
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Glidescope AVL | Overall Successful Tracheal Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL | 72 Participants |
| King Vision Channeled VL | Overall Successful Tracheal Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL | 61 Participants |
| King Vision Non-Channeled (Standard) VL | Overall Successful Tracheal Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL | 72 Participants |
Secondary
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
Time frame: During laryngoscopy and endotracheal tube placement
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Glidescope AVL | First-attempt Successful Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL | 64 Participants |
| King Vision Channeled VL | First-attempt Successful Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL | 53 Participants |
| King Vision Non-Channeled (Standard) VL | First-attempt Successful Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL | 67 Participants |
Other Pre-specified
Final Intubation Time for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL
Total time for placing the endotracheal tube (ETT) through the vocal cords
Time frame: During laryngoscopy and endotracheal tube placement
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glidescope AVL | Final Intubation Time for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL | 46.1 seconds | Standard Deviation 27.4 |
| King Vision Channeled VL | Final Intubation Time for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL | 44.9 seconds | Standard Deviation 21.5 |
| King Vision Non-Channeled (Standard) VL | Final Intubation Time for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL | 47.0 seconds | Standard Deviation 24.3 |