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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
Sponsor:
Information provided by (Responsible Party):
Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Obesity Device: McGrath Device: GlideScope Device: Direct Macintosh Laryngoscopy Device: Video-Mac Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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


  3. 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.


  4. 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



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Roya Yumul, MD, PhD Cedars-Sinai Medical Center
More Information
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Responsible Party: Roya Yumul, M.D.,PhD., Residency program director, Department of anesthesiology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01114945    
Other Study ID Numbers: Pro00019199
First Posted: May 3, 2010    Key Record Dates
Results First Posted: March 9, 2016
Last Update Posted: April 6, 2016
Last Verified: March 2016
Keywords provided by Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center:
Direct Laryngoscopy
Video-Mac
GlideScope
McGrath
Laryngoscopy
 Bariatrics
Glottic view
Airway intubating devices
Tracheal intubation