Study: Study to Compare Video Miller Device to Direct Laryngoscopy

Cedars-Sinai Medical Center28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Surgeries Undergoing General Anesthesia

Interventions

VideoMillerDEVICE

Video-Miller laryngoscope, using the screen (Video laryngoscopy group)

Direct LaryngoscopyDEVICE

Video-Miller laryngoscope, without screen (Direct laryngoscopy group)

Eligibility

Sex: ALLMax age: 3 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients aged 3 years or younger undergoing anesthesia requiring endotracheal intubation. 2. Obtaining signed the informed consent by their parents or legal guardian. 3. American Society of Anaesthesiologists (ASA) physical status classification I - II or III Exclusion Criteria: 1. Patients deemed to be at significant airway risk necessitating an awake fiber optic intubation 2. Patients with facial abnormalities, and/or oral-pharyngeal malformation. 3. Emergency operation

Locations (1)

Cedars Sinai Medical center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Time to Obtain Glottic View

Time to obtain glottic view (from initial insertion of laryngoscope blade to obtain glottic view)

Time frame: 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

Time frame: 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 frame: Time from initial insertion of laryngoscope blade to confirm w/ CO2 waveform

Secondary Outcomes

Glottis Visualization Using POGO Score

POGO score represents the percentage of glottic opening seen (from 0-100%)

Time frame: 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 1. Full view of glottis 68-74% \<1% 2. 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

Time frame: 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

Data from ClinicalTrials.gov

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