Study: Study to Compare Video Miller Device to Direct Laryngoscopy
|ClinicalTrials.gov Identifier: NCT01371032|
Recruitment Status : Enrolling by invitation
First Posted : June 10, 2011
Last Update Posted : April 4, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Surgeries Undergoing General Anesthesia||Device: VideoMiller Device: Direct Laryngoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Factorial Assignment|
|Official 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|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Video-Miller laryngoscope
using the screen (Video laryngoscopy group)
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)
- Intubation time [ Time Frame: 3 minutes ]Start to end of intubation procedure (approximately 3 minutes) Evaluate whether tracheal intubation with the videomiller device increases the glottic view and decreases the time between intubation instrumentation.
- Glottis visualization using Cormack Lehane and POGO score [ Time Frame: 1 minute ]Start of intubation procedure (approximately 1 minute) Glottic (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the two devices.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371032
|United States, California|
|Cedars Sinai Medical center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Roya Yumul, MD,PhD||Cedars-Sinai Medical Center|
|Study Chair:||Ronald H Wender, MD||Cedars-Sinai Medical Center|