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To compare the laryngoscopy view using two standard clinical devices, the Macintosh and Miller laryngoscopy blades, in infants between one day and two years of age.
Miller blades (straight blades) are more commonly used than MacIntosh blades (curved) in pediatric clinical practice in some institutions especially in infants. The anatomy of infant airway has traditionally been considered to lend itself to advantages of the Miller blade. Some argue that the Miller blade offers a superior view of the laryngeal inlet because it lifts the epiglottis. However, others use the Miller blade to expose the larynx without lifting the epiglottis, supposedly to avoid traumatizing it. Despite the long-standing use of these blades, more than 50 years, no systematic study has ever compared the laryngoscopy views of the Miller and Macintosh blades in infants.
The primary hypothesis of this study is to compare the view of the larynx with Miller blade while lifting the epiglottis to the Macintosh blade lifting the tongue, in infants and children <2 years of age. However, views will be obtained with the Miller and Macintosh blades both lifting and not lifting the epiglottis and comparisons between pairs of measurements will be performed. In order for to detect superiority of one technique over the other, we will need a difference in the POGO scores of 25 points with a standard deviation of 25 points, yielding a sample size of 15 children in each group. To account for photographic difficulties, unreadable photos as well as dropouts, we will enroll 25 children in each group. Therefore a total of 50 children will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macintosh laryngoscope blade | Active Comparator | 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 Percent of Glottic Opening (POGO) score by a blinded assessor. |
|
| Miller laryngoscope blade | Active Comparator | 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 percent of glottic opening score by a blinded assessor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laryngoscope blade | Device | The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades lifting and not lifting the epiglotis |
|
| Measure | Description | Time Frame |
|---|---|---|
| The View of the Larynx (Glottis Opening) as Determined by POGO Score (Percentage of Glottic Opening). | Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the Macintosh blade lifting the tongue | 30 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Glottic Opening With the Miller Blade Lifting the Epiglottis and Tongue | Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the same blade lifting the tongue | 30 seconds |
| Percent of Glottic Opening With the MAC Blade Lifting the Tongue and the Epiglottis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerrold Lerman, MD | SUNY at Buffalo, Women and Children's Hospital of Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women and Childrens Hospital of Buffalo | Buffalo | New York | 14222 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25062740 | Derived | Passi Y, Sathyamoorthy M, Lerman J, Heard C, Marino M. Comparison of the laryngoscopy views with the size 1 Miller and Macintosh laryngoscope blades lifting the epiglottis or the base of the tongue in infants and children <2 yr of age. Br J Anaesth. 2014 Nov;113(5):869-74. doi: 10.1093/bja/aeu228. Epub 2014 Jul 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The View of the Larynx (Glottis Opening) as Determined by POGO Score (Percentage of Glottic Opening). | Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the Macintosh blade lifting the tongue | Posted | Mean | 95% Confidence Interval | percentage of Glottic opening | 30 seconds |
|
Single assessment, immediately after induction of general anesthesia
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jerrold Lerman | Women and Children's Hospital of buffalo | 716 878 7701 | jerrold.lerman@gmail.com |
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|
The 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. |
| 30 seconds |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| months |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| percent of glottic opening | Median | Inter-Quartile Range | percentage |
|
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 |
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| Secondary | Percent of Glottic Opening With the Miller Blade Lifting the Epiglottis and Tongue | Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the same blade lifting the tongue | Posted | Mean | 95% Confidence Interval | percent of glottic opening | 30 seconds |
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| Secondary | Percent of Glottic Opening With the MAC Blade Lifting the Tongue and the Epiglottis | The 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. | Posted | Mean | 95% Confidence Interval | percent of glottic opening | 30 seconds |
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| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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 | 0 | 25 | 0 | 25 |
| Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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