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Study: Study to Compare Video Miller Device to Direct Laryngoscopy

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ClinicalTrials.gov Identifier: NCT01371032
Recruitment Status : Enrolling by invitation
First Posted : June 10, 2011
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Roya Yumul, M.D.,PhD., 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.


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
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

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)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371032


Locations
United States, California
Cedars Sinai Medical center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
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

Responsible Party: Roya Yumul, M.D.,PhD., Residency program director, Department of anesthesiology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01371032     History of Changes
Other Study ID Numbers: Pro00024542
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No