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

Not Applicable

Completed

• Conditions: Warming Systems During Surgery
• Interventions: Device: heated pad; Device: heated blanket

• Registration Number: NCT01094119
• Lead Sponsor: The Cleveland Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-03-25
• Study First Posted: 2010-03-26
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Results First Submitted: 2016-11-29
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-08
• Last Update Submitted: 2017-03-08
• Results First Posted: 2017-04-19
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LMA PerfecTemp system	heated pad	Patients will be warmed during surgery with the PerfecTemp heated pad .
Bair Hugger heated blanket	heated blanket	Patients will be warmed during surgery with the Bair Hugger heated blanket.

Primary Outcome Measures

Name	Time	Method
Time Weighted Average Core Temperature	from tracheal intubation to 3 hours after or tracheal extubation	Time weighted average core temperature (esophogeal temperature) from tracheal intubation to 3 hours after or tracheal extubation

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients With Temperatures Above 36 Degree	at the end of surgery	Proportion of patients with esophogeal temperatures above 36 degree at the end of surgery

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States