Trial Outcomes & Findings for Comparing the Laryngoscopy View Using Miller and Macintosh Laryngoscopy Blades in Infants Under Two Years of Age (NCT NCT01717872)
NCT ID: NCT01717872
Last Updated: 2017-03-20
Results Overview
Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the Macintosh blade lifting the tongue
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
30 seconds
Results posted on
2017-03-20
Participant Flow
Participant milestones
| Measure |
Macintosh Laryngoscope Blade
A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis
|
Miller Laryngoscope Blade
A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing the Laryngoscopy View Using Miller and Macintosh Laryngoscopy Blades in Infants Under Two Years of Age
Baseline characteristics by cohort
| Measure |
Macintosh Laryngoscope Blade
n=25 Participants
A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis
|
Miller Laryngoscope Blade
n=25 Participants
A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
15 months
n=99 Participants
|
14 months
n=107 Participants
|
14 months
n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
percent of glottic opening
|
80 percentage
n=99 Participants
|
80 percentage
n=107 Participants
|
80 percentage
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 secondsPercent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the Macintosh blade lifting the tongue
Outcome measures
| Measure |
Macintosh Laryngoscope Blade
n=25 Participants
A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The percent of glottic opening (POGO) score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis
|
Miller Laryngoscope Blade
n=25 Participants
A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis
|
|---|---|---|
|
The View of the Larynx (Glottis Opening) as Determined by POGO Score (Percentage of Glottic Opening).
|
84 percentage of Glottic opening
Interval 76.0 to 92.0
|
78 percentage of Glottic opening
Interval 70.0 to 87.0
|
SECONDARY outcome
Timeframe: 30 secondsPercent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the same blade lifting the tongue
Outcome measures
| Measure |
Macintosh Laryngoscope Blade
n=25 Participants
A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The percent of glottic opening (POGO) score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis
|
Miller Laryngoscope Blade
n=25 Participants
A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis
|
|---|---|---|
|
Percent of Glottic Opening With the Miller Blade Lifting the Epiglottis and Tongue
|
78.4 percent of glottic opening
Interval 70.0 to 87.0
|
76 percent of glottic opening
Interval 67.1 to 84.9
|
SECONDARY outcome
Timeframe: 30 secondsThe MAC blade was inserted under the tongue to view the percent glottic opening and compared with the view with the same blade lifting the epiglottis to view the percent glottic opening.
Outcome measures
| Measure |
Macintosh Laryngoscope Blade
n=25 Participants
A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The percent of glottic opening (POGO) score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis
|
Miller Laryngoscope Blade
n=25 Participants
A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis
|
|---|---|---|
|
Percent of Glottic Opening With the MAC Blade Lifting the Tongue and the Epiglottis
|
84.4 percent of glottic opening
Interval 76.5 to 92.3
|
67.2 percent of glottic opening
Interval 56.1 to 78.3
|
Adverse Events
Macintosh Laryngoscope Blade
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Miller Laryngoscope Blade
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Macintosh Laryngoscope Blade
n=25 participants at risk
A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis
|
Miller Laryngoscope Blade
n=25 participants at risk
A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
|
0.00%
0/25 • Single assessment, immediately after induction of general anesthesia
|
0.00%
0/25 • Single assessment, immediately after induction of general anesthesia
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jerrold Lerman
Women and Children's Hospital of buffalo
Phone: 716 878 7701
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place