A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air

Completed · Not applicable

Conditions studied: Warming Systems During Surgery

In brief

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.

Key facts

Study ID

NCT01094119

Run by

The Cleveland Clinic

People needed

70

Starts

2010-03-01

Expected to finish

2010-08-01

Last updated by the study team

2017-04-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body-mass index 20-36 kg/m2
• Age 18-75 yrs
• ASA Physical Status 1-3
• Supine position (with or without lithotomy)

You may not qualify if…

• Pre-operative fever
• Serious skin lesions
• And contraindication to either PerfecTemp or forced-air warming

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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