N/A
N=130
McGrath Videolaryngoscopy and Direct Laryngoscopy in Morbidly Obese Patients
Morbid Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03467048 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Classification of Glottis Visualization — 45; 23; 11; 16 Participants — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- McGrath videolaryngoscopy (Device); Direct laryngoscopy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Classification of Glottis Visualization |
45; 23; 11; 16; 7; 14 | <0.01 sig |
| SECONDARY Number of Intubation Failure |
2; 5 | 0.08 |
| SECONDARY Number of Intubation Attempts Among Those With Successful Intubation |
61; 56; 3; 2 | 0.41 |
Summary
Our goal is to compare conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for endotracheal intubation in very morbidly obese patients undergoing non-cardiac surgery. Specifically, we propose to test the primary hypotheses that videolaryngoscopy improves visualization of the vocal cords, defined with modified Cormack and Lehane classification, compared to direct laryngoscopy.
Eligibility Criteria
Inclusion Criteria
- Elective surgery requiring oral endotracheal intubation for general anesthesia;
- Anticipated extubation in the operating room;
- American Society of Anesthesiologists (ASA) physical status 1-3;
- Age between 18 and 99 years;
- Body Mass index ≥ 40 kg/m2.
Exclusion Criteria
- Refusal of participation by attending anesthesiologist;
- Indicated rapid sequence induction for any reason including, but not limited to high risk of aspiration
- Indicated fiberoptic awake intubation.
Data sourced from ClinicalTrials.gov (NCT03467048). 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.