Comparative Effectiveness of Intubating Devices in the Morbidly Obese

Study Overview
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Brief Summary
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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.

Detailed Description
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Hypothesis: the use of a video laryngoscope will improve the glottic view compared to direct laryngoscopy, and secondarily, use of the video laryngoscope will reduce the time required to achieve successful tracheal intubation in patients undergoing bariatric surgery. (Weight loss surgery). The three types of video laryngoscopy devices include; the Verethon GlideScope, LMA McGrath and Karl-Storz Video-Mac.

Official Title
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A Prospective Study Comparing Video Laryngoscopy Devices to Direct Laryngoscopy for Tracheal Intubation of Patients Undergoing Bariatric Surgery

Conditions
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Obesity

Intervention / Treatment
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* Device: McGrath
* Device: GlideScope
* Device: Direct Macintosh Laryngoscopy
* Device: Video-Mac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a documented body mass index (BMI) of >35. Patients scheduled to undergo inpatient surgery procedures under general anesthesia. Willingness and ability to sign an informed consent document 18 - 80 years of age American Society of Anesthesiologists (ASA) Class II- III adults of either sex. Exclusion Criteria: Patients who are deemed to be such a significant of an airway risk that they necessitate awake fiberoptic intubation Patients with a history facial abnormalities, oral-pharyngeal cancer or reconstructive surgery Emergency surgeries Pregnancy The inability to tolerate 0.2mg of glycopyrrolate based on tachycardia. Any other conditions or use of any medication which may interfere with the conduct of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video-Mac<br>Video-Mac device used during intubation procedure | Device: Video-Mac<br>* Intubation with the Video-Mac device<br>|
| Experimental: GlideScope<br>GlideScope device used during intubation procedure | Device: GlideScope<br>* Intubation with the GlideScope device<br>|
| Experimental: McGrath<br>McGrath device used during intubation procedure | Device: McGrath<br>* Intubation with the McGrath device<br>|
| Active Comparator: Direct Macintosh Laryngoscopy<br>Direct Macintosh Laryngoscopy (DL) used during intubation procedure | Device: Direct Macintosh Laryngoscopy<br>* Intubation with Direct Macintosh Laryngoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation Time Using a Stop Watch | 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. | up to 3 minutes | 
| Time to Obtain Glottis Visualization (Seconds) | 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 | up to 1 minute | 
| Percentage of Glottic Opening (POGO) [%] | 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. | up to 1 minute | 
| Glottis View Using the Cormack Lehane Score | 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 | Up to 1 minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Direct Laryngoscopy, Video-Mac, GlideScope, McGrath, Laryngoscopy, Bariatrics, Glottic view, Airway intubating devices, Tracheal intubation