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Completed

NCT Number: NCT01371032

Study: Study to Compare Video Miller Device to Direct Laryngoscopy

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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Key information

Conditions

Surgeries Undergoing General Anesthesia

Age range

Up to 3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VideoMiller

Device

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

direct laryngoscopy

Device

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

Primary outcomes

  1. Time to Obtain Glottic View

    Time frame: Times following initial insertion of laryngoscope blade to obtain glottic view

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

  2. Intubation Time

    Time frame: Times from insertion of laryngoscope blade to placement of tracheal tube

    Times following initial insertion of laryngoscope blade to placement of tracheal tube

  3. Time From Insertion of Laryngoscope Blade to Confirm w/ CO2 Waveform

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

    Time following initial insertion of laryngoscope blade to confirm w/ CO2 waveform

Secondary outcomes

  1. Glottis Visualization Using POGO Score

    Time frame: During intubation procedure, up to 3 minutes

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

  2. Glottis Visualization Using Cormack Lehane

    Time frame: During intubation procedure, up to 3 minutes

    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

  3. Number of Participants Intubated With 1 and > 1 Intubation Attempts

    Time frame: During intubation procedure, up to 3 minutes

    Number of Participants intubated after 1 intubation attempt and Number of Participants intubated after > 1 intubation attempts

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 10, 2011
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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