Study: Study to Compare Video Miller Device to Direct Laryngoscopy

Not Applicable

Completed

• Conditions: Surgeries Undergoing General Anesthesia
• Interventions: Device: VideoMiller; Device: Direct Laryngoscopy

• Registration Number: NCT01371032
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-10
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2021-07-08
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-25
• Last Update Submitted: 2021-08-25
• Results First Posted: 2021-09-21
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video-Miller laryngoscope	VideoMiller	using the screen (Video laryngoscopy group)
Direct laryngoscopy	Direct Laryngoscopy	without use the screen (Direct laryngoscopy group)

Primary Outcome Measures

Name	Time	Method
Time to Obtain Glottic View	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)
Intubation Time	Times from insertion of laryngoscope blade to placement of tracheal tube	Times following initial insertion of laryngoscope blade to placement of tracheal tube
Time From Insertion of Laryngoscope Blade to Confirm w/ CO2 Waveform	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 Outcome Measures

Name	Time	Method
Number of Participants Intubated With 1 and > 1 Intubation Attempts	During intubation procedure, up to 3 minutes	Number of Participants intubated after 1 intubation attempt and Number of Participants intubated after \> 1 intubation attempts
Glottis Visualization Using Cormack Lehane	During intubation procedure, up to 3 minutes	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
Glottis Visualization Using POGO Score	During intubation procedure, up to 3 minutes	POGO score represents the percentage of glottic opening seen (from 0-100%)

Trial Locations

Locations (1)

Cedars Sinai Medical center; 🇺🇸 Los Angeles, California, United States