Study: Study to Compare Video Miller Device to Direct Laryngoscopy
This study is enrolling participants by invitation only.
Sponsor:
Cedars-Sinai Medical Center
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: February 14, 2012
Last verified: February 2012
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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 |
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 (approximatly 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 (approximatly 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: | June 2012 |
| Estimated Primary Completion Date: | March 2012 (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:
- Patients aged 3 years or younger undergoing anesthesia requiring endotracheal intubation.
- Obtaining signed the informed consent by their parents or legal guardian.
- ASA physical status I - II or III
Exclusion Criteria:
- Patients deemed to be at significant airway risk necessitating an awake fiber optic intubation
- Patients with facial abnormalities, and/or oral-pharyngeal malformation.
- Emergency operation
Contacts and Locations
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: | February 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 21, 2013