Comparative Effectiveness of Intubating Devices in the Morbidly Obese
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|ClinicalTrials.gov Identifier: NCT01114945|
Recruitment Status : Completed
First Posted : May 3, 2010
Results First Posted : March 9, 2016
Last Update Posted : April 6, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Device: McGrath Device: GlideScope Device: Direct Macintosh Laryngoscopy Device: Video-Mac||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||121 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Prospective Study Comparing Video Laryngoscopy Devices to Direct Laryngoscopy for Tracheal Intubation of Patients Undergoing Bariatric Surgery|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
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
- 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
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): NCT01114945
|United States, California|
|Cedars Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Roya Yumul, MD, PhD||Cedars-Sinai Medical Center|