Study: Study to Compare Video Miller Device to Direct Laryngoscopy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01371032
First received: June 9, 2011
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Surgeries Undergoing General Anesthesia
Device: VideoMiller
Device: Direct Laryngoscopy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Intubation time [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]
    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:
  • Glottis visualization using Cormack Lehane and POGO score [ Time Frame: 1 minute ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: June 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
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. ASA physical status 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: June 9, 2011
Last Updated: August 5, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 22, 2014