Comparative Effectiveness of Intubating Devices in the Morbidly Obese
This study has been completed.
Sponsor:
Cedars-Sinai Medical Center
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
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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
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 |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013