Comparative Effectiveness of Intubating Devices in the Morbidly Obese

Phase 4

Completed

• Conditions: Obesity
• Interventions: Device: Video-Mac; Device: GlideScope; Device: McGrath; Device: Direct Macintosh Laryngoscopy

• Registration Number: NCT01114945
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-30
• Study Start: 2010-05
• Study First Posted: 2010-05-03
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2015-09-03
• Results First Submitted QC: 2016-02-11
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-08
• Results First Posted: 2016-03-09
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video-Mac	Video-Mac	Video-Mac device used during intubation procedure
GlideScope	GlideScope	GlideScope device used during intubation procedure
McGrath	McGrath	McGrath device used during intubation procedure
Direct Macintosh Laryngoscopy	Direct Macintosh Laryngoscopy	Direct Macintosh Laryngoscopy (DL) used during intubation procedure

Primary Outcome Measures

Name	Time	Method
Glottis View Using the Cormack Lehane Score	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
Intubation Time Using a Stop Watch	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)	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) [%]	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.

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States