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

The Cleveland Clinic70 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Warming Systems During Surgery

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Time Weighted Average Core Temperature

Time weighted average core temperature (esophogeal temperature) from tracheal intubation to 3 hours after or tracheal extubation

Time frame: from tracheal intubation to 3 hours after or tracheal extubation

Secondary Outcomes

Proportion of Patients With Temperatures Above 36 Degree

Proportion of patients with esophogeal temperatures above 36 degree at the end of surgery

Time frame: at the end of surgery