Intubation Clinical Trial
— RAMPOfficial title:
An Evaluation Of The Rapid Airway Management Positioner (RAMP) In Obese Patients Undergoing Gastric Bypass Or Laparoscopic Gastric Banding (Lap-Band) Surgery
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Hermann Hospital | Houston, | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time and number of attempts required; | duration of intubation | No | |
Primary | Level of difficulty for intubation | duration of intubation | No | |
Primary | Degree of irritation of the pharynx, epiglottis, and arytenoids | post operative, immediately and 24 hours later | No | |
Secondary | vital signs, oxygen saturation, end-tidal carbon dioxide | duration of intubation | Yes |
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