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The purpose of this study is to compare:
the standard pediatric intubation instrument (Miller blade) used as direct laryngoscopy during tracheal intubation to the VideoMiller device (the standard pediatric blade with a camera attached, giving indirect view of the vocal cords in the screen). This intubation device is used to place the tube in the trachea to keep the patient breathing during the surgery procedure.
The anesthesiologist obtains a better view of the vocal cords looking at the screen provided by the VideoMiller.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video-Miller laryngoscope | Active Comparator | using the screen (Video laryngoscopy group) |
|
| Direct laryngoscopy | Active Comparator | without use the screen (Direct laryngoscopy group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VideoMiller | Device | Video-Miller laryngoscope, using the screen (Video laryngoscopy group) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Obtain Glottic View | Time to obtain glottic view (from initial insertion of laryngoscope blade to obtain glottic view) | Times following initial insertion of laryngoscope blade to obtain glottic view |
| Intubation Time | Times following initial insertion of laryngoscope blade to placement of tracheal tube | Times from insertion of laryngoscope blade to placement of tracheal tube |
| Time From Insertion of Laryngoscope Blade to Confirm w/ CO2 Waveform | Time following initial insertion of laryngoscope blade to confirm w/ CO2 waveform | Time from initial insertion of laryngoscope blade to confirm w/ CO2 waveform |
| Measure | Description | Time Frame |
|---|---|---|
| Glottis Visualization Using POGO Score | POGO score represents the percentage of glottic opening seen (from 0-100%) | During intubation procedure, up to 3 minutes |
| Glottis Visualization Using Cormack Lehane |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roya Yumul, MD,PhD | Cedars-Sinai Medical Center | Principal Investigator |
| Ronald H Wender, MD | Cedars-Sinai Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical center | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37171122 | Derived | Lingappan K, Neveln N, Arnold JL, Fernandes CJ, Pammi M. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates. Cochrane Database Syst Rev. 2023 May 12;5(5):CD009975. doi: 10.1002/14651858.CD009975.pub4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Video-Miller Laryngoscope | using the screen (Video laryngoscopy group) VideoMiller: Video-Miller laryngoscope, using the screen (Video laryngoscopy group) |
| FG001 | Direct Laryngoscopy | without use the screen (Direct laryngoscopy group) Direct Laryngoscopy: Video-Miller laryngoscope, without screen (Direct laryngoscopy group) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Video-Miller Laryngoscope | using the screen (Video laryngoscopy group) VideoMiller: Video-Miller laryngoscope, using the screen (Video laryngoscopy group) |
| BG001 | Direct Laryngoscopy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Time to Obtain Glottic View | Time to obtain glottic view (from initial insertion of laryngoscope blade to obtain glottic view) | Posted | Mean | Standard Deviation | seconds | Times following initial insertion of laryngoscope blade to obtain glottic view |
|
One day
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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 | Video-Miller Laryngoscope | Video-Miller laryngoscopy group (using the screen of the Video-Miller laryngoscope device for intubation) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Roya Yumul, MD, PhD | Cedars Sinai Medical Center | 310-423-1682 | Roya.Yumul@cshs.org |
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| Direct Laryngoscopy | Device | Video-Miller laryngoscope, without screen (Direct laryngoscopy group) |
|
Glottic visualization comparison between the two devices. Grade Description Approximate frequency Likelihood of difficult intubation
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
| During intubation procedure, up to 3 minutes |
| Number of Participants Intubated With 1 and > 1 Intubation Attempts | Number of Participants intubated after 1 intubation attempt and Number of Participants intubated after > 1 intubation attempts | During intubation procedure, up to 3 minutes |
without use the screen (Direct laryngoscopy group)
Direct Laryngoscopy: Video-Miller laryngoscope, without screen (Direct laryngoscopy group)
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | Kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Laryngoscope Blade Size | Laryngoscope blades are used for examination of the interior of the larynx and for placement of an endotracheal tube. The Miller Laryngoscope Blades sizes (The most popular of the straight types) go from 0 to 4. For the pediatric ages used in this studies the sizes used were 0 and 1. | Number | Count of Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Intubation Time | Times following initial insertion of laryngoscope blade to placement of tracheal tube | Posted | Mean | Standard Deviation | Seconds | Times from insertion of laryngoscope blade to placement of tracheal tube |
|
|
|
| Primary | Time From Insertion of Laryngoscope Blade to Confirm w/ CO2 Waveform | Time following initial insertion of laryngoscope blade to confirm w/ CO2 waveform | Posted | Mean | Standard Deviation | seconds | Time from initial insertion of laryngoscope blade to confirm w/ CO2 waveform |
|
|
|
| Secondary | Glottis Visualization Using POGO Score | POGO score represents the percentage of glottic opening seen (from 0-100%) | Posted | Mean | Standard Deviation | percentage of glottic opening | During intubation procedure, up to 3 minutes |
|
|
|
| Secondary | Glottis Visualization Using Cormack Lehane | Glottic visualization comparison between the two devices. Grade Description Approximate frequency Likelihood of difficult intubation
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 | Posted | Number | Count of Participants | During intubation procedure, up to 3 minutes |
|
|
|
| Secondary | Number of Participants Intubated With 1 and > 1 Intubation Attempts | Number of Participants intubated after 1 intubation attempt and Number of Participants intubated after > 1 intubation attempts | Posted | Number | participants | During intubation procedure, up to 3 minutes |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Direct Laryngoscopy | Direct laryngoscopy group (using the video-Miller laryngoscope, without access to the screen). | 0 | 14 | 0 | 14 | 0 | 14 |
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