Trial Outcomes & Findings for Stylet Angle for McGrath Videolaryngoscopy (NCT NCT03000088)
NCT ID: NCT03000088
Last Updated: 2017-04-13
Results Overview
Recruitment status
COMPLETED
Target enrollment
140 participants
Primary outcome timeframe
10 minutes around intubation
Results posted on
2017-04-13
Participant Flow
This study enrolled patients scheduled for elective surgery requiring orotracheal intubation in our hospital. The last patient completed in August 2016.
Participant milestones
| Measure |
60° Angle Group
intubate using McGrath Videolaryngoscope with 60° angled stylet
intubate with 60° angled stylet
|
90°Angle Group
intubate using McGrath Videolaryngoscope with 90° angled stylet
intubate with 60° angled stylet
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
COMPLETED
|
70
|
70
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stylet Angle for McGrath Videolaryngoscopy
Baseline characteristics by cohort
| Measure |
60° Angle Group
n=70 Participants
intubate using McGrath Videolaryngoscope with 60° angled stylet
intubate with 60° angled stylet
|
90°Angle Group
n=70 Participants
intubate using McGrath Videolaryngoscope with 90° angled stylet
intubate with 60° angled stylet
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 14 • n=99 Participants
|
41 years
STANDARD_DEVIATION 14 • n=107 Participants
|
41 years
STANDARD_DEVIATION 14 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
|
Thyromental distance
|
9.2 cm
STANDARD_DEVIATION 1.3 • n=99 Participants
|
9.2 cm
STANDARD_DEVIATION 1.4 • n=107 Participants
|
9.2 cm
STANDARD_DEVIATION 1.3 • n=206 Participants
|
|
Mouth opening
|
5.4 cm
STANDARD_DEVIATION 1.1 • n=99 Participants
|
5.2 cm
STANDARD_DEVIATION 0.9 • n=107 Participants
|
5.3 cm
STANDARD_DEVIATION 1.0 • n=206 Participants
|
|
range of motion of cervical spine
normal
|
69 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
range of motion of cervical spine
reduced
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
range of motion of cervical spine
fixed
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
upper incisors status
normal
|
68 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
138 Participants
n=206 Participants
|
|
upper incisors status
absent
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
upper incisors status
fixed
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Mallampati score
Mallampati score 1
|
41 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Mallampati score
Mallampati score 2
|
22 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Mallampati score
Mallampati score 3
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 10 minutes around intubationOutcome measures
| Measure |
90°Angle Group
n=70 Participants
intubate using McGrath Videolaryngoscope with 90° angled stylet
intubate with 60° angled stylet
|
60° Angle Group
n=70 Participants
intubate using McGrath Videolaryngoscope with 60° angled stylet
intubate with 60° angled stylet
|
|---|---|---|
|
Time to Intubation
|
32.5 seconds
Standard Deviation 9.4
|
29.3 seconds
Standard Deviation 6.4
|
Adverse Events
60° Angle Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
90°Angle Group
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