Trial Outcomes & Findings for Comparison Study in Adult Surgical Patients of 5 Airway Devices (NCT NCT00602979)
NCT ID: NCT00602979
Last Updated: 2017-05-19
Results Overview
Percentage distribution of Cook's modification of Cormack-Lehane's grading system. This is a classification that records the best laryngeal view obtained with or without anterior laryngeal pressure. Each study subject will receive a grade of 1, 2A, 2B, 3A, 3B, or 4 in the Cormack-Lehane grading system. Grades 1 and 2A classify as an easy view: when the laryngeal inlet is visible. Grades 2B and 3A classify as restricted: when the posterior glottic structures are visible or the epiglottis is visible and can be lifted. Grades 3B and 4 classify as difficult: when the epiglottis cannot be lifted or when no laryngeal structures are visible. Cook's modification of Cormack-Lehane's Grades 1=1, 2=2A,3=2B, 4=3A, 5=3B, 6=4.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
240 participants
Primary outcome timeframe
1 time during laryngoscopy
Results posted on
2017-05-19
Participant Flow
Participant milestones
| Measure |
Macintosh Laryngoscope
Macintosh laryngoscope (control group/direct laryngoscopy) - current standard
Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation.
|
Airtraq Optical Laryngoscope
Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)
Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation.
|
Storz DCI Video Laryngoscope
Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)
Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation
|
GlideScope Video Laryngoscope
GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)
GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
|
McGRATH Video Laryngoscope
McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)
McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
48
|
48
|
48
|
48
|
48
|
|
Overall Study
COMPLETED
|
45
|
45
|
45
|
45
|
45
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
3
|
3
|
Reasons for withdrawal
| Measure |
Macintosh Laryngoscope
Macintosh laryngoscope (control group/direct laryngoscopy) - current standard
Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation.
|
Airtraq Optical Laryngoscope
Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)
Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation.
|
Storz DCI Video Laryngoscope
Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)
Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation
|
GlideScope Video Laryngoscope
GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)
GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
|
McGRATH Video Laryngoscope
McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)
McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
3
|
2
|
3
|
|
Overall Study
Failed Intubation
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Comparison Study in Adult Surgical Patients of 5 Airway Devices
Baseline characteristics by cohort
| Measure |
Macintosh Laryngoscope
n=48 Participants
Macintosh laryngoscope (control group/direct laryngoscopy) - current standard
Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation.
|
Airtraq Optical Laryngoscope
n=48 Participants
Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)
Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation.
|
Storz DCI Video Laryngoscope
n=48 Participants
Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)
Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation
|
GlideScope Video Laryngoscope
n=48 Participants
GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)
GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
|
McGRATH Video Laryngoscope
n=48 Participants
McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)
McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 16.9 • n=5 Participants
|
46.1 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
47.8 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
50.0 years
STANDARD_DEVIATION 15.2 • n=4 Participants
|
49.3 years
STANDARD_DEVIATION 15.8 • n=21 Participants
|
48.7 years
STANDARD_DEVIATION 15.4 • n=10 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
114 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
126 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 1 time during laryngoscopyPercentage distribution of Cook's modification of Cormack-Lehane's grading system. This is a classification that records the best laryngeal view obtained with or without anterior laryngeal pressure. Each study subject will receive a grade of 1, 2A, 2B, 3A, 3B, or 4 in the Cormack-Lehane grading system. Grades 1 and 2A classify as an easy view: when the laryngeal inlet is visible. Grades 2B and 3A classify as restricted: when the posterior glottic structures are visible or the epiglottis is visible and can be lifted. Grades 3B and 4 classify as difficult: when the epiglottis cannot be lifted or when no laryngeal structures are visible. Cook's modification of Cormack-Lehane's Grades 1=1, 2=2A,3=2B, 4=3A, 5=3B, 6=4.
Outcome measures
| Measure |
Macintosh Laryngoscope
n=45 Participants
Macintosh laryngoscope (control group/direct laryngoscopy) - current standard
Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation.
|
Airtraq Optical Laryngoscope
n=45 Participants
Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)
Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation.
|
Storz DCI Video Laryngoscope
n=45 Participants
Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)
Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation
|
GlideScope Video Laryngoscope
n=45 Participants
GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)
GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
|
McGRATH Video Laryngoscope
n=45 Participants
McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)
McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
|
|---|---|---|---|---|---|
|
Percentage Distribution of Cook's Modification of Cormack-Lehane's Grading System. Each Study Subject Will Receive a Grade of 1, 2A, 2B, 3A, 3B, or 4 in the Cormack-Lehane Grading System.
|
1.98 units on a scale
Standard Deviation 1.96
|
1.18 units on a scale
Standard Deviation 0.44
|
1.27 units on a scale
Standard Deviation 0.54
|
1.47 units on a scale
Standard Deviation 0.59
|
1.13 units on a scale
Standard Deviation 0.34
|
Adverse Events
Macintosh Laryngoscope
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Airtraq Optical Laryngoscope
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Storz DCI Video Laryngoscope
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GlideScope Video Laryngoscope
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
McGRATH Video Laryngoscope
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Macintosh Laryngoscope
n=48 participants at risk
Macintosh laryngoscope (control group/direct laryngoscopy) - current standard
Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation.
|
Airtraq Optical Laryngoscope
n=48 participants at risk
Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)
Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation.
|
Storz DCI Video Laryngoscope
n=48 participants at risk
Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)
Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation
|
GlideScope Video Laryngoscope
n=48 participants at risk
GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)
GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
|
McGRATH Video Laryngoscope
n=48 participants at risk
McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)
McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
|
|---|---|---|---|---|---|
|
Eye disorders
Corneal Laceration
|
2.1%
1/48 • Number of events 1
|
0.00%
0/48
|
0.00%
0/48
|
0.00%
0/48
|
0.00%
0/48
|
|
Vascular disorders
Iliac Vein Rupture
|
2.1%
1/48 • Number of events 1
|
0.00%
0/48
|
0.00%
0/48
|
0.00%
0/48
|
0.00%
0/48
|
|
Blood and lymphatic system disorders
Right Tonsillar Pillar Laceration
|
0.00%
0/48
|
0.00%
0/48
|
0.00%
0/48
|
0.00%
0/48
|
2.1%
1/48 • Number of events 1
|
Other adverse events
| Measure |
Macintosh Laryngoscope
n=48 participants at risk
Macintosh laryngoscope (control group/direct laryngoscopy) - current standard
Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation.
|
Airtraq Optical Laryngoscope
n=48 participants at risk
Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)
Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation.
|
Storz DCI Video Laryngoscope
n=48 participants at risk
Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)
Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation
|
GlideScope Video Laryngoscope
n=48 participants at risk
GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)
GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
|
McGRATH Video Laryngoscope
n=48 participants at risk
McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)
McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
|
|---|---|---|---|---|---|
|
General disorders
Swollen Lip
|
0.00%
0/48
|
0.00%
0/48
|
0.00%
0/48
|
0.00%
0/48
|
2.1%
1/48 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place