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

Study Overview
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Brief Summary
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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.

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

Conditions
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Warming Systems During Surgery

Intervention / Treatment
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* Device: heated blanket
* Device: heated pad


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body-mass index 20-36 kg/m2 Age 18-75 yrs ASA Physical Status 1-3 Supine position (with or without lithotomy) Exclusion Criteria: Pre-operative fever Serious skin lesions And contraindication to either PerfecTemp or forced-air warming

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bair Hugger heated blanket<br>Patients will be warmed during surgery with the Bair Hugger heated blanket. | Device: heated blanket<br>* heated blanket<br>* Other names: Bair Hugger;|
| Active Comparator: LMA PerfecTemp system<br>Patients will be warmed during surgery with the PerfecTemp heated pad . | Device: heated pad<br>* patients will be warmed with a heated pad during surgery.<br>* Other names: LMA PerfecTemp system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Weighted Average Core Temperature | Time weighted average core temperature (esophogeal temperature) from tracheal intubation to 3 hours after or tracheal extubation | from tracheal intubation to 3 hours after or tracheal extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With Temperatures Above 36 Degree | Proportion of patients with esophogeal temperatures above 36 degree at the end of surgery | at the end of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heated blanket, heated pad