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

NCT01094119 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-04-19

Study results available
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Summary

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.

Conditions

  • Warming Systems During Surgery

Interventions

DEVICE

heated blanket

heated blanket

DEVICE

heated pad

patients will be warmed with a heated pad during surgery.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Daniel I Sessler, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01094119 on ClinicalTrials.gov