Comparative Effectiveness of Intubating Devices in the Morbidly Obese

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01114945
First received: April 23, 2010
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Obesity
Device: MacGrath
Device: GlideScope
Device: Direct Macintosh 4 Laryngoscopy
Device: Video-Mac
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Official Title: A Prospective Study Comparing Video Laryngoscopy Devices to Direct Laryngoscopy for Tracheal Intubation of Patients Undergoing Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Intubation Time using a stop watch [ Time Frame: up to 3 minutes ] [ Designated as safety issue: No ]
    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, glidoscope, and McGrath vs direct laryngoscopy.


Secondary Outcome Measures:
  • Glottis Visualization using Cormack Lehane and percentage of glottic opening (POGO) score [ Time Frame: up to 1 minute ] [ Designated as safety issue: No ]
    Start of intubation procedure (approximatly 1 minute) Glottic (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the four devices in patients undergoing bariatric surgery


Enrollment: 80
Study Start Date: February 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Video-Mac Device: Video-Mac
Comparison of 4 different airway intubating devices
GlideScope Device: GlideScope
Comparison of 4 different airway intubating devices
McGrath Device: MacGrath
Comparison of 4 different airway intubating devices
Active Comparator: Direct Macintosh 4 Laryngoscopy Device: Direct Macintosh 4 Laryngoscopy
Comparison of 4 different airway intubating devices

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114945

Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Roya Yumul, MD, PhD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Roya Yumul, M.D.,PhD., Residency program director, Department of anesthesiology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01114945     History of Changes
Other Study ID Numbers: Pro00019199
Study First Received: April 23, 2010
Last Updated: February 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Direct Laryngoscopy
Video-Mac
GlideScope
McGrath
Laryngoscopy
Bariatrics
Glottic view
Airway intubating devices
Tracheal intubation

ClinicalTrials.gov processed this record on October 23, 2014