Study:
A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air
Rationale:
n/a
Purpose:
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:
1. intraoperative core temperatures are superior with PerfecTemp than upper-body
forced-air warming
2. final intraoperative core temperature is non-inferior with PerfecTemp than upper-body
forced-air warming
3. final intraoperative core temperature is superior with PerfecTemp than upper-body
forced-air warming.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Warming Systems During Surgery |
Device: heated blanket
Device: heated pad |
N/A |
Verified by
Outcomes Research Consortium
January, 2011
Sponsored by: Outcomes Research Consortium
Information provided by: Outcomes Research Consortium
ClinicalTrials.gov identifier: NCT01094119
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Cleveland Clinic
Cleveland, Ohio 44195
United States
Daniel I Sessler, MD., Principal Investigator