Study: Study to Compare Video Miller Device to Direct Laryngoscopy

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

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 Overview

• Status: Completed
• Conditions: Surgeries Undergoing General Anesthesia
• Intervention / Treatment: Device: VideoMiller; Device: Direct Laryngoscopy

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Roya Yumul, MD,PhD, Cedars-Sinai Medical Center; Study Chair: Ronald H Wender, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 9, 2011
• First Submitted That Met QC Criteria: June 9, 2011
• First Posted (Estimate): June 10, 2011

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Pro00024542

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No