Comparative Effectiveness of Intubating Devices in the Morbidly Obese
This prospective, randomized study will compare the effectiveness of 4 different airway intubating devices which are most commonly used.
The four different devices are as follows: McGrath video laryngoscope, GlideScope video laryngoscope, Video-Mac video laryngoscope, and Macintosh size 4 direct laryngoscope.
|Obesity||Device: McGrath Device: GlideScope Device: Direct Macintosh Laryngoscopy Device: Video-Mac||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
|Official Title:||A Prospective Study Comparing Video Laryngoscopy Devices to Direct Laryngoscopy for Tracheal Intubation of Patients Undergoing Bariatric Surgery|
- Intubation Time Using a Stop Watch [ Time Frame: up to 3 minutes ]Evaluate if the time it takes to achieve successful tracheal intubation in patients undergoing bariatric surgery (weight loss surgery) will be reduced using the video-mac, glidescope, and McGrath vs direct laryngoscopy.
- Time to Obtain Glottis Visualization (Seconds) [ Time Frame: up to 1 minute ]
It is the time (seconds) following initial insertion of laryngoscope blade to obtain a glottic view.
Start of intubation procedure to Glottic view (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the four devices in patients undergoing bariatric surgery
- Percentage of Glottic Opening (POGO) [%] [ Time Frame: up to 1 minute ]
POGO score of 100% denotes visualization of the entire glottic opening in linear fashion from the anterior commissure to the posterior cartilages. If none of the glottic opening is seen, then the POGO score is 0%.
View of the glottic opening (0-100%) during the intubation process.
- Glottis View Using the Cormack Lehane Score [ Time Frame: Up to 1 minute ]
Cormack Lehane score classification:
Grade 1: Most of the glottis is visible Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen Grade 3: Only the epiglottis is visible Grade 4: No laryngeal structures are visible
|Study Start Date:||May 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Video-Mac device used during intubation procedure
Intubation with the Video-Mac device
GlideScope device used during intubation procedure
Intubation with the GlideScope device
McGrath device used during intubation procedure
Intubation with the McGrath device
Active Comparator: Direct Macintosh Laryngoscopy
Direct Macintosh Laryngoscopy (DL) used during intubation procedure
Device: Direct Macintosh Laryngoscopy
Intubation with Direct Macintosh Laryngoscope
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114945
|United States, California|
|Cedars Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Roya Yumul, MD, PhD||Cedars-Sinai Medical Center|