Trial Outcomes & Findings for Vocal Cord Views With the Classical Miller, Wis-Hipple and C-MAC Size 1 Blades in Young Children (NCT NCT03053583)
NCT ID: NCT03053583
Last Updated: 2025-04-15
Results Overview
The percentage of vocal cord opening (POGO) is the percent of the vocal cords that is visible during laryngoscopy. Minimum is obviously 0 and maximum 100 as in percents. The more visible the vocal cords the better the view or outcome. The mean or measure of central tendency was reported together with the 25th to 75th percentile as a measure of dispersion.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
96 participants
Primary outcome timeframe
10 minutes
Results posted on
2025-04-15
Participant Flow
Only 96 children had interpretable photos of the larynx: C-MAC included 36, WIs-Hipple 31 and Miller 29 children.
A total of 96 children were consented for the trial
Participant milestones
| Measure |
Miller Laryngoscope Blade
A photo of the best glottic view will be taken during laryngoscopy using Miller blade. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score assesses the percent of the glottic opening that can be seen with each blade
|
Wis-Hipple Laryngoscope Blade
A photo of the best glottic view will be taken during laryngoscopy using Wis- Hipple blade. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score assesses the percent of the glottic opening that can be seen with each blade
|
C-Mac Laryngoscope Blade
An image of the best glottic view will be saved on C-MAC monitor's SD card during laryngoscopy using C-MAC straight blade. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score assesses the percent of the glottic opening that can be seen with each blade
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
31
|
36
|
|
Overall Study
COMPLETED
|
29
|
31
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vocal Cord Views With the Classical Miller, Wis-Hipple and C-MAC Size 1 Blades in Young Children
Baseline characteristics by cohort
| Measure |
Miller Laryngoscope Blade
n=29 Participants
A photo of the best glottic view will be taken during laryngoscopy using Miller blade. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score assesses the percent of the glottic opening that can be seen with each blade
|
Wis-Hipple Laryngoscope Blade
n=31 Participants
A photo of the best glottic view will be taken during laryngoscopy using Wis- Hipple blade. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score assesses the percent of the glottic opening that can be seen with each blade
|
C-Mac Laryngoscope Blade
n=36 Participants
An image of the best glottic view will be saved on C-MAC monitor's SD card during laryngoscopy using C-MAC straight blade. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score assesses the percent of the glottic opening that can be seen with each blade
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
Age (months)
|
15 months
STANDARD_DEVIATION 8.1 • n=5 Participants
|
15 months
STANDARD_DEVIATION 7 • n=7 Participants
|
17 months
STANDARD_DEVIATION 8.8 • n=5 Participants
|
15 months
STANDARD_DEVIATION 7.35 • n=4 Participants
|
|
Sex/Gender, Customized
Sex
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
31 participants
n=7 Participants
|
36 participants
n=5 Participants
|
96 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 10 minutesThe percentage of vocal cord opening (POGO) is the percent of the vocal cords that is visible during laryngoscopy. Minimum is obviously 0 and maximum 100 as in percents. The more visible the vocal cords the better the view or outcome. The mean or measure of central tendency was reported together with the 25th to 75th percentile as a measure of dispersion.
Outcome measures
| Measure |
Miller Laryngoscope Blade
n=29 Participants
The percent of vocal cords (glottic opening) (POGO) score will be the estimated percent of the vocal cords visible in a photo of the larynx during laryngoscopy with a Miller laryngoscope blade in each child.
|
Wis-Hipple Laryngoscope Blade
n=31 Participants
The percent of vocal cords (glottic opening) (POGO) score will be the estimated percent of the vocal cords visible in a photo of the laryngeal view during laryngoscopy with a Wish-Hipple laryngoscope blade in each child.
|
C-Mac Laryngoscope Blade
n=36 Participants
The percent of vocal cord (glottic opening) (POGO) score will be the estimated percent of the vocal cords visible in a photo of the laryngeal view taken from the monitor of the C-MAC during laryngoscopy with a C-Mac laryngoscope blade and a direct view of the vocal cords using the C-Mac laryngoscope blade in each child.
|
|---|---|---|---|
|
Percentage of Vocal Cord Opening
|
100 percent
Interval 95.0 to 100.0
|
98 percent
Interval 92.0 to 100.0
|
100 percent
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 30 minutes from induction to tracheal intubationPopulation: Median and range for the subjective ease of laryngoscopy and intubation
"Subjective ease of intubation" scale ranges from 1 to 10 where 1 was difficult and 10 was easy. Median and range for this nonparametric score.
Outcome measures
| Measure |
Miller Laryngoscope Blade
n=29 Participants
The percent of vocal cords (glottic opening) (POGO) score will be the estimated percent of the vocal cords visible in a photo of the larynx during laryngoscopy with a Miller laryngoscope blade in each child.
|
Wis-Hipple Laryngoscope Blade
n=31 Participants
The percent of vocal cords (glottic opening) (POGO) score will be the estimated percent of the vocal cords visible in a photo of the laryngeal view during laryngoscopy with a Wish-Hipple laryngoscope blade in each child.
|
C-Mac Laryngoscope Blade
n=36 Participants
The percent of vocal cord (glottic opening) (POGO) score will be the estimated percent of the vocal cords visible in a photo of the laryngeal view taken from the monitor of the C-MAC during laryngoscopy with a C-Mac laryngoscope blade and a direct view of the vocal cords using the C-Mac laryngoscope blade in each child.
|
|---|---|---|---|
|
Subjective Ease of Laryngoscopy and Intubation
|
10 score on a scale
Interval 10.0 to 10.0
|
10 score on a scale
Interval 10.0 to 10.0
|
10 score on a scale
Interval 10.0 to 10.0
|
SECONDARY outcome
Timeframe: post laryngoscopypercentage of oxygen saturation
Outcome measures
| Measure |
Miller Laryngoscope Blade
n=29 Participants
The percent of vocal cords (glottic opening) (POGO) score will be the estimated percent of the vocal cords visible in a photo of the larynx during laryngoscopy with a Miller laryngoscope blade in each child.
|
Wis-Hipple Laryngoscope Blade
n=31 Participants
The percent of vocal cords (glottic opening) (POGO) score will be the estimated percent of the vocal cords visible in a photo of the laryngeal view during laryngoscopy with a Wish-Hipple laryngoscope blade in each child.
|
C-Mac Laryngoscope Blade
n=36 Participants
The percent of vocal cord (glottic opening) (POGO) score will be the estimated percent of the vocal cords visible in a photo of the laryngeal view taken from the monitor of the C-MAC during laryngoscopy with a C-Mac laryngoscope blade and a direct view of the vocal cords using the C-Mac laryngoscope blade in each child.
|
|---|---|---|---|
|
Percent of Oxygen Saturation
|
100 percentage of oxygen saturation
Interval 98.0 to 100.0
|
100 percentage of oxygen saturation
Interval 99.0 to 100.0
|
100 percentage of oxygen saturation
Interval 99.0 to 100.0
|
Adverse Events
Miller Laryngoscope Blade
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wis-Hipple Laryngoscope Blade
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
C-Mac Laryngoscope Blade
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