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

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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
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