Trial Outcomes & Findings for Study: Study to Compare Video Miller Device to Direct Laryngoscopy (NCT NCT01371032)
NCT ID: NCT01371032
Last Updated: 2021-09-21
Results Overview
Time to obtain glottic view (from initial insertion of laryngoscope blade to obtain glottic view)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Times following initial insertion of laryngoscope blade to obtain glottic view
Results posted on
2021-09-21
Participant Flow
Participant milestones
| Measure |
Video-Miller Laryngoscope
using the screen (Video laryngoscopy group)
VideoMiller: Video-Miller laryngoscope, using the screen (Video laryngoscopy group)
|
Direct Laryngoscopy
without use the screen (Direct laryngoscopy group)
Direct Laryngoscopy: Video-Miller laryngoscope, without screen (Direct laryngoscopy group)
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study: Study to Compare Video Miller Device to Direct Laryngoscopy
Baseline characteristics by cohort
| Measure |
Video-Miller Laryngoscope
n=14 Participants
using the screen (Video laryngoscopy group)
VideoMiller: Video-Miller laryngoscope, using the screen (Video laryngoscopy group)
|
Direct Laryngoscopy
n=14 Participants
without use the screen (Direct laryngoscopy group)
Direct Laryngoscopy: Video-Miller laryngoscope, without screen (Direct laryngoscopy group)
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.6 months
STANDARD_DEVIATION 4 • n=5 Participants
|
9.6 months
STANDARD_DEVIATION 7 • n=7 Participants
|
8 months
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Weight
|
8 Kg
STANDARD_DEVIATION 3 • n=5 Participants
|
10 Kg
STANDARD_DEVIATION 4 • n=7 Participants
|
9 Kg
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Height
|
71 cm
STANDARD_DEVIATION 13 • n=5 Participants
|
69 cm
STANDARD_DEVIATION 13 • n=7 Participants
|
70 cm
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Laryngoscope Blade Size
Laryngoscope Blade size 0
|
12 Count of Participants
n=5 Participants
|
13 Count of Participants
n=7 Participants
|
25 Count of Participants
n=5 Participants
|
|
Laryngoscope Blade Size
Laryngoscope Blade size 1
|
2 Count of Participants
n=5 Participants
|
1 Count of Participants
n=7 Participants
|
3 Count of Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Times following initial insertion of laryngoscope blade to obtain glottic viewTime to obtain glottic view (from initial insertion of laryngoscope blade to obtain glottic view)
Outcome measures
| Measure |
Video-Miller Laryngoscope
n=14 Participants
using the screen (Video laryngoscopy group)
VideoMiller: Video-Miller laryngoscope, using the screen (Video laryngoscopy group)
|
Direct Laryngoscopy
n=14 Participants
without use the screen (Direct laryngoscopy group)
Direct Laryngoscopy: Video-Miller laryngoscope, without screen (Direct laryngoscopy group)
|
|---|---|---|
|
Time to Obtain Glottic View
|
9.2 seconds
Standard Deviation 5
|
8.4 seconds
Standard Deviation 6.4
|
PRIMARY outcome
Timeframe: Times from insertion of laryngoscope blade to placement of tracheal tubeTimes following initial insertion of laryngoscope blade to placement of tracheal tube
Outcome measures
| Measure |
Video-Miller Laryngoscope
n=14 Participants
using the screen (Video laryngoscopy group)
VideoMiller: Video-Miller laryngoscope, using the screen (Video laryngoscopy group)
|
Direct Laryngoscopy
n=14 Participants
without use the screen (Direct laryngoscopy group)
Direct Laryngoscopy: Video-Miller laryngoscope, without screen (Direct laryngoscopy group)
|
|---|---|---|
|
Intubation Time
|
21 Seconds
Standard Deviation 11
|
28 Seconds
Standard Deviation 20
|
PRIMARY outcome
Timeframe: Time from initial insertion of laryngoscope blade to confirm w/ CO2 waveformTime following initial insertion of laryngoscope blade to confirm w/ CO2 waveform
Outcome measures
| Measure |
Video-Miller Laryngoscope
n=14 Participants
using the screen (Video laryngoscopy group)
VideoMiller: Video-Miller laryngoscope, using the screen (Video laryngoscopy group)
|
Direct Laryngoscopy
n=14 Participants
without use the screen (Direct laryngoscopy group)
Direct Laryngoscopy: Video-Miller laryngoscope, without screen (Direct laryngoscopy group)
|
|---|---|---|
|
Time From Insertion of Laryngoscope Blade to Confirm w/ CO2 Waveform
|
61 seconds
Standard Deviation 37
|
59 seconds
Standard Deviation 30
|
SECONDARY outcome
Timeframe: During intubation procedure, up to 3 minutesPOGO score represents the percentage of glottic opening seen (from 0-100%)
Outcome measures
| Measure |
Video-Miller Laryngoscope
n=14 Participants
using the screen (Video laryngoscopy group)
VideoMiller: Video-Miller laryngoscope, using the screen (Video laryngoscopy group)
|
Direct Laryngoscopy
n=14 Participants
without use the screen (Direct laryngoscopy group)
Direct Laryngoscopy: Video-Miller laryngoscope, without screen (Direct laryngoscopy group)
|
|---|---|---|
|
Glottis Visualization Using POGO Score
|
94 percentage of glottic opening
Standard Deviation 5.6
|
93.2 percentage of glottic opening
Standard Deviation 14
|
SECONDARY outcome
Timeframe: During intubation procedure, up to 3 minutesGlottic visualization comparison between the two devices. Grade Description Approximate frequency Likelihood of difficult intubation 1. Full view of glottis 68-74% \<1% 2. a Partial view of glottis 21-24% 4.3-13.4% 2b Only posterior extremity of glottis seen or only arytenoid cartilages 3.3-6.5% 65-67.4% 3 Only epiglottis seen, none of glottis seen 1.2-1.6% 80-87.5% 4 Neither glottis nor epiglottis seen very rare
Outcome measures
| Measure |
Video-Miller Laryngoscope
n=14 Participants
using the screen (Video laryngoscopy group)
VideoMiller: Video-Miller laryngoscope, using the screen (Video laryngoscopy group)
|
Direct Laryngoscopy
n=14 Participants
without use the screen (Direct laryngoscopy group)
Direct Laryngoscopy: Video-Miller laryngoscope, without screen (Direct laryngoscopy group)
|
|---|---|---|
|
Glottis Visualization Using Cormack Lehane
Cormack Lehane score 1
|
12 Count of Participants
|
12 Count of Participants
|
|
Glottis Visualization Using Cormack Lehane
Cormack Lehane score 2
|
2 Count of Participants
|
2 Count of Participants
|
SECONDARY outcome
Timeframe: During intubation procedure, up to 3 minutesNumber of Participants intubated after 1 intubation attempt and Number of Participants intubated after \> 1 intubation attempts
Outcome measures
| Measure |
Video-Miller Laryngoscope
n=14 Participants
using the screen (Video laryngoscopy group)
VideoMiller: Video-Miller laryngoscope, using the screen (Video laryngoscopy group)
|
Direct Laryngoscopy
n=14 Participants
without use the screen (Direct laryngoscopy group)
Direct Laryngoscopy: Video-Miller laryngoscope, without screen (Direct laryngoscopy group)
|
|---|---|---|
|
Number of Participants Intubated With 1 and > 1 Intubation Attempts
Intubation attempt= 1
|
11 participants
|
12 participants
|
|
Number of Participants Intubated With 1 and > 1 Intubation Attempts
Intubation attempts > 1
|
3 participants
|
2 participants
|
Adverse Events
Video-Miller Laryngoscope
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Direct Laryngoscopy
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