Difficult Intubation
Conditions
Brief summary
The investigators plan to conduct a randomized trial comparing the intubation success rate and time of the King Vision Video Laryngoscope to the Glidescope video laryngoscope in order to demonstrate the comparability of the devices.
Detailed description
Both the King Vision and Glidescope video laryngoscopes are advanced airway devices that are relatively low cost and are designed to improve the efficiency of both routine and difficult intubation. Both systems use disposable blades, which eliminates the need for blade sterilization and may minimize the risk of infectious exposure to patients and improve cost and efficiency associated with the sterilization processing of non-disposable laryngoscopes. The Glidescope has been commercially available longer than the King Vision, and has been more frequently studied. Although similar in many respects, the King Vision and Glidescope systems have differing designs which may result in differences in speed and success in the management of routine and/or difficult airways.
Interventions
Intubation via King Vision Video Laryngoscope
Intubation via Glidescope Video Laryngoscope
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients scheduled for elective, ambulatory surgery requiring general anesthesia and endotracheal intubation
Exclusion criteria
* Patients who require rapid sequence induction and intubation or fiberoptic intubation. * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Until Intubation With Each Device | <100 seconds | time from the introduction of the laryngoscope into the oral cavity to endotracheal tube reaching the glottic aperture |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pulse Oximetry Saturation Value Reading During Intubation | <100 seconds | — |
| Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm) | <100 seconds | Assisted Maneuvers can include laryngeal manipulation, head lift, Backward Upward Rightward Pressure, stylet removed, Cricoid pressure, scope manipulation and bougie. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | during and immediately after procedure (approx 180 minutes) | Notation of any injury to lips, teeth, soft tissue. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| King Vision Video Laryngoscope The patient would be randomized to intubation via use of the King Vision VL then Glidescope VL
King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope
Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope | 18 |
| Glidescope Video Laryngoscope The patient would be randomized to intubation via use of the Glidescope VL then King Vision VL
King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope
Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope | 22 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | device failure | 0 | 1 |
Baseline characteristics
| Characteristic | Glidescope Video Laryngoscope | Total | King Vision Video Laryngoscope |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 7 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 33 Participants | 15 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 22 participants | 40 participants | 18 participants |
| Sex: Female, Male Female | 11 Participants | 21 Participants | 10 Participants |
| Sex: Female, Male Male | 11 Participants | 19 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 22 |
| other Total, other adverse events | 2 / 18 | 2 / 22 |
| serious Total, serious adverse events | 0 / 18 | 0 / 22 |
Outcome results
Primary
Time Until Intubation With Each Device
time from the introduction of the laryngoscope into the oral cavity to endotracheal tube reaching the glottic aperture
Time frame: <100 seconds
| Arm | Measure | Value (MEAN) |
|---|---|---|
| King Vision Video Laryngoscope | Time Until Intubation With Each Device | 32.3 seconds |
| Glidescope Video Laryngoscope | Time Until Intubation With Each Device | 27.2 seconds |
Secondary
Mean Pulse Oximetry Saturation Value Reading During Intubation
Time frame: <100 seconds
| Arm | Measure | Value (MEAN) |
|---|---|---|
| King Vision Video Laryngoscope | Mean Pulse Oximetry Saturation Value Reading During Intubation | 97.39 percentage of oxygen saturation |
| Glidescope Video Laryngoscope | Mean Pulse Oximetry Saturation Value Reading During Intubation | 97.0 percentage of oxygen saturation |
Secondary
Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm)
Assisted Maneuvers can include laryngeal manipulation, head lift, Backward Upward Rightward Pressure, stylet removed, Cricoid pressure, scope manipulation and bougie.
Time frame: <100 seconds
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| King Vision Video Laryngoscope | Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm) | stylet removed | 0 assisted maneuvers |
| King Vision Video Laryngoscope | Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm) | bougie | 0 assisted maneuvers |
| King Vision Video Laryngoscope | Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm) | Cricoid pressure | 0 assisted maneuvers |
| King Vision Video Laryngoscope | Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm) | scope manipulation | 0 assisted maneuvers |
| King Vision Video Laryngoscope | Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm) | Backward Upward Rightward Pressure | 0 assisted maneuvers |
| Glidescope Video Laryngoscope | Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm) | scope manipulation | 1 assisted maneuvers |
| Glidescope Video Laryngoscope | Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm) | Backward Upward Rightward Pressure | 1 assisted maneuvers |
| Glidescope Video Laryngoscope | Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm) | stylet removed | 1 assisted maneuvers |
| Glidescope Video Laryngoscope | Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm) | Cricoid pressure | 3 assisted maneuvers |
| Glidescope Video Laryngoscope | Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm) | bougie | 1 assisted maneuvers |
Other Pre-specified
Number of Participants With Adverse Events
Notation of any injury to lips, teeth, soft tissue.
Time frame: during and immediately after procedure (approx 180 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| King Vision Video Laryngoscope | Number of Participants With Adverse Events | 2 participants |
| Glidescope Video Laryngoscope | Number of Participants With Adverse Events | 2 participants |