Video Laryngoscopic Device Usage in Novice Users
Conditions
Brief summary
In this study, the investigators compare the effectiveness of two relatively new video laryngoscopes, McGrath MAC (Covidien, Dublin Ireland) and the King Vision (King Systems, Noblesville, IN), by practitioners experienced in airway management but with limited exposure to these two devices. Our hypothesis was that, the McGrath MAC device would require fewer intubation attempts and shorter intubation times than the King Vision when performed by novice users.
Interventions
PROCEDUREKing Vision video laryngoscope
Patient intubated with the King Vision Video Laryngoscope
PROCEDUREMcGrath MAC video laryngoscope
Intubation with the McGrath MAC video laryngoscope
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All interested airway providers (Residents, Attendings, Certified Nurse Anesthetist and * Student Registered Nurse Anesthetist) will be eligible to be included. -
Exclusion criteria
* All patients with difficult airways as determined by history or physical exam (limited oral opening, limited cervical extension, receding chin, Mallampati class III or IV).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intubation Success on First Attempt as Measured by End Tidal Carbon Dioxide | participants were followed up to the point the video device is removed from the airway, classified as under 90 seconds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Intubation | Intubation time was initiated at the time of entry of the study device beyond the teeth/gum line and the intubation time was stopped when the study device was removed beyond the same point. | Number of patients intubated in less than 90 seconds |
Participant flow
Pre-assignment details
In the King Vision arm one patient was removed from the surgery secondary to a planned procedure change and another was removed from the study because they declined to participate after already signing consent for this study. This explains the 31 patient enrollment in the King Vision arm.
Participants by arm
| Arm | Count |
|---|---|
| King Vision Video Laryngoscope Patient intubated with the King Vision Video Laryngoscope
Intubation with the King Vision video laryngoscope | 33 |
| McGrath MAC Video Laryngoscope Patient intubated with the McGrath MAC Video Laryngoscope
Intubation with the McGrath MAC video laryngoscope | 33 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | King Vision Video Laryngoscope | McGrath MAC Video Laryngoscope | Total |
|---|---|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 15 | 52 years STANDARD_DEVIATION 21 | 52 years STANDARD_DEVIATION 17 |
| Region of Enrollment United States | 33 participants | 33 participants | 66 participants |
| Sex/Gender, Customized Female | 15 participants | 18 participants | 33 participants |
| Sex/Gender, Customized Male | 18 participants | 15 participants | 33 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 33 |
| serious Total, serious adverse events | 0 / 31 | 0 / 33 |
Outcome results
Primary
Intubation Success on First Attempt as Measured by End Tidal Carbon Dioxide
Time frame: participants were followed up to the point the video device is removed from the airway, classified as under 90 seconds.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| King Vision Video Laryngoscope | Intubation Success on First Attempt as Measured by End Tidal Carbon Dioxide | 24 participants |
| McGrath MAC Video Laryngoscope | Intubation Success on First Attempt as Measured by End Tidal Carbon Dioxide | 33 participants |
Secondary
Time to Intubation
Number of patients intubated in less than 90 seconds
Time frame: Intubation time was initiated at the time of entry of the study device beyond the teeth/gum line and the intubation time was stopped when the study device was removed beyond the same point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| King Vision Video Laryngoscope | Time to Intubation | 10 participants |
| McGrath MAC Video Laryngoscope | Time to Intubation | 25 participants |