Use of New Supraglottic Airway Devices in Severely Obese Patients: A Feasibility Study
The purpose of this study is to determine whether two new airway devices used during anesthesia called iGEL™ and KING-LTS-DTM work well and are safe in obese patients. They both work well in thin patients, but have not been tested in obese patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
|Official Title:||Use of New Supraglottic Airway Devices in Severely Obese Patients: A Feasibility Study|
- Airway Sealing Pressure [ Time Frame: 1-3 hours ] [ Designated as safety issue: Yes ]Oropharyngeal leak pressure in cm H2O for the duration of the case at 1, 15, 30, 60, 120 minutes.
- Difference in insertion time for one of the supraglottic airway devices [ Time Frame: 1-3 hours ] [ Designated as safety issue: Yes ]Effective airway time (time required to place the endotracheal tube/ supraglottic airway device).
|Study Start Date:||July 2011|
|Study Completion Date:||October 2012|
|Estimated Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Active Comparator: IGel
Subjects will receive an IGel(TM) airway induction and maintenance of positive pressure ventilation
iGEL(TM) airway will be used for induction and maintenance of positive pressure ventilation
Active Comparator: King Airway
Subject will receive a KING-LTS-D(TM) for induction and maintenance of positive pressure ventilation
Device: King airway
KING-LTS-D(TM) airway will be used for induction and maintenance of positive pressure ventilation
|United States, Kentucky|
|University of Louisville Hospital|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Detlef Obal, MD||University of Louisville|