Phase 4
N=121
Comparative Effectiveness of Intubating Devices in the Morbidly Obese
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01114945 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Intubation Time Using a Stop Watch — 43; 22; 45; 40 Seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- McGrath (Device); GlideScope (Device); Direct Macintosh Laryngoscopy (Device); Video-Mac (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intubation Time Using a Stop Watch |
43; 22; 45; 40; 70; 49 | — |
| PRIMARY Time to Obtain Glottis Visualization (Seconds) |
20; 9; 12; 10 | — |
| PRIMARY Percentage of Glottic Opening (POGO) [%] |
57; 84; 87; 91 | — |
| PRIMARY Glottis View Using the Cormack Lehane Score |
12; 16; 18; 23; 8; 12 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01114945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.