Study: Study to Compare Video Miller Device to Direct Laryngoscopy

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Prospective Study to Compare the Video Miller Device to Direct Laryngoscopy Using a Standard Pediatric Miller Blade for Tracheal Intubation of Children < 3 Years of Age Undergoing General Anesthesia

Conditions
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Surgeries Undergoing General Anesthesia

Intervention / Treatment
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* Device: VideoMiller
* Device: Direct Laryngoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 3 years or younger undergoing anesthesia requiring endotracheal intubation. Obtaining signed the informed consent by their parents or legal guardian. American Society of Anaesthesiologists (ASA) physical status classification I - II or III Exclusion Criteria: Patients deemed to be at significant airway risk necessitating an awake fiber optic intubation Patients with facial abnormalities, and/or oral-pharyngeal malformation. Emergency operation

Ages Eligible for Study
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Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Video-Miller laryngoscope<br>using the screen (Video laryngoscopy group) | Device: VideoMiller<br>* Video-Miller laryngoscope, using the screen (Video laryngoscopy group)<br>|
| Active Comparator: Direct laryngoscopy<br>without use the screen (Direct laryngoscopy group) | Device: Direct Laryngoscopy<br>* Video-Miller laryngoscope, without screen (Direct laryngoscopy group)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Glottic visualization comparison between the two devices. Grade Description Approximate frequency Likelihood of difficult intubation Full view of glottis 68-74% <1% 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 | 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 |