Trial Outcomes & Findings for Comparison Study of the McGrath MAC Video Laryngoscope With the King Vision (NCT NCT02316769)
NCT ID: NCT02316769
Last Updated: 2017-03-10
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
participants were followed up to the point the video device is removed from the airway, classified as under 90 seconds.
Results posted on
2017-03-10
Participant Flow
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.
Participant milestones
| Measure |
King Vision Video Laryngoscope
Patient intubated with the King Vision Video Laryngoscope
Intubation with the King Vision video laryngoscope
|
McGrath MAC Video Laryngoscope
Patient intubated with the McGrath MAC Video Laryngoscope
Intubation with the McGrath MAC video laryngoscope
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
31
|
33
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
King Vision Video Laryngoscope
Patient intubated with the King Vision Video Laryngoscope
Intubation with the King Vision video laryngoscope
|
McGrath MAC Video Laryngoscope
Patient intubated with the McGrath MAC Video Laryngoscope
Intubation with the McGrath MAC video laryngoscope
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Comparison Study of the McGrath MAC Video Laryngoscope With the King Vision
Baseline characteristics by cohort
| Measure |
King Vision Video Laryngoscope
n=33 Participants
Patient intubated with the King Vision Video Laryngoscope
Intubation with the King Vision video laryngoscope
|
McGrath MAC Video Laryngoscope
n=33 Participants
Patient intubated with the McGrath MAC Video Laryngoscope
Intubation with the McGrath MAC video laryngoscope
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 15 • n=5 Participants
|
52 years
STANDARD_DEVIATION 21 • n=7 Participants
|
52 years
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
18 participants
n=5 Participants
|
15 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
15 participants
n=5 Participants
|
18 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
33 participants
n=7 Participants
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: participants were followed up to the point the video device is removed from the airway, classified as under 90 seconds.Outcome measures
| Measure |
King Vision Video Laryngoscope
n=31 Participants
Patient intubated with the King Vision Video Laryngoscope
Intubation with the King Vision video laryngoscope
|
McGrath MAC Video Laryngoscope
n=33 Participants
Patient intubated with the McGrath MAC Video Laryngoscope
Intubation with the McGrath MAC video laryngoscope
|
|---|---|---|
|
Intubation Success on First Attempt as Measured by End Tidal Carbon Dioxide
|
24 participants
|
33 participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
King Vision Video Laryngoscope
n=31 Participants
Patient intubated with the King Vision Video Laryngoscope
Intubation with the King Vision video laryngoscope
|
McGrath MAC Video Laryngoscope
n=33 Participants
Patient intubated with the McGrath MAC Video Laryngoscope
Intubation with the McGrath MAC video laryngoscope
|
|---|---|---|
|
Time to Intubation
|
10 participants
|
25 participants
|
Adverse Events
King Vision Video Laryngoscope
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
McGrath MAC Video Laryngoscope
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place