Comparative Effectiveness of Intubating Devices in the Morbidly Obese

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Device: Video-Mac; Device: GlideScope; Device: McGrath; Device: Direct Macintosh Laryngoscopy

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 Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video-Mac; Video-Mac device used during intubation procedure	Device: Video-Mac; Intubation with the Video-Mac device
Experimental: GlideScope; GlideScope device used during intubation procedure	Device: GlideScope; Intubation with the GlideScope device
Experimental: McGrath; McGrath device used during intubation procedure	Device: McGrath; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: April 23, 2010
• First Submitted That Met QC Criteria: April 30, 2010
• First Posted (Estimate): May 3, 2010

Study Record Updates

• Last Update Posted (Estimate): April 6, 2016
• Last Update Submitted That Met QC Criteria: March 8, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Laryngoscopy; Tracheal intubation; Bariatrics; GlideScope; Glottic view; McGrath; Direct Laryngoscopy; Video-Mac; Airway intubating devices
• Other Study ID Numbers: Pro00019199