N/A
N=51
Evaluation of the Rapid Airway Management Positioner
Endotracheal Intubation · Rapid Airway Management Positioner
Bottom Line
View on ClinicalTrials.gov: NCT00581230 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Ease of Mask Ventilation as Assessed by Han Class — 15; 24; 18; 15 participants — p=0.0003
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laryngoscopy with RAMP (Device); Laryngoscopy without RAMP (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ease of Mask Ventilation as Assessed by Han Class |
15; 24; 18; 15; 13; 7 | 0.0003 sig |
| PRIMARY Glottic View as Assessed by the Cormack and Lehane Classification |
17; 28; 11; 13; 12; 6 | 0.0001 sig |
Summary
The purpose of this study is to determine if the Rapid Airway Management Positioner (RAMP, AirPal, Center Valley, PA) is a useful positioning device for direct laryngoscopy and tracheal intubation in obese patients undergoing gastric bypass or laparoscopic gastric banding surgery.
Eligibility Criteria
Inclusion Criteria
- The 50 subjects will be adult surgical candidates age 18-80, ASA I-III, BMI > 30 kg/m2 presenting for gastric bypass or laparoscopic gastric banding surgery who require general anesthesia.
Exclusion Criteria
- Patients will be excluded if it is determined that an awake intubation should be performed. Mallampati IV and ASA IV-V patients will also be excluded, as well as patients with unstable cervical, thoracic and/or lumbar fracture.
Data sourced from ClinicalTrials.gov (NCT00581230). 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.