A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air
Recently, a novel posterior heating system has been developed that provides enhanced pressure relief: the Laryngeal Mask Airway (LMA) PerfecTemp. Anactodal experience with this FDA-approved system suggests that the PerfecTemp warmer is effective, even in open abdominal surgery. The investigators therefore propose to test the hypothesis that intraoperative distal esophageal (core) temperatures with PerfecTemp warming are non-inferior to upper-body forced-air warming in patients undergoing open major abdominal surgery under general anesthesia.
Secondary hypotheses include that:
- intraoperative core temperatures are superior with PerfecTemp than upper-body forced-air warming
- final intraoperative core temperature is non-inferior with PerfecTemp than upper-body forced-air warming
- final intraoperative core temperature is superior with PerfecTemp than upper-body forced-air warming.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
|Official Title:||A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air|
- PerfecTemp compared to forced-air warming [ Time Frame: two hours of surgery ] [ Designated as safety issue: No ]temperature area under the curve (36*C baseline)
|Study Start Date:||March 2010|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Bair Hugger heated blanket
Patients will be warmed during surgery with the Bair Hugger heated blanket.
Device: heated blanket
Other Name: Bair Hugger
Active Comparator: LMA PerfecTemp system
Patients will be warmed during surgery with the PerfecTemp heated pad .
Device: heated pad
patients will be warmed with a heated pad during surgery.
Other Name: LMA PerfecTemp system
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094119
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Daniel I Sessler, MD||The Cleveland Clinic|