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

NeuroTherapia, Inc.

Status: Completed

Conditions: Warming Systems During Surgery

Treatments: Device: heated blanket; Device: heated pad

Study type: Interventional

Funder types: Other

Identifiers

NCT01094119

10-146

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Bair Hugger heated blanket

Active Comparator group

Description:

Patients will be warmed during surgery with the Bair Hugger heated blanket.

Treatment:

Device: heated blanket

LMA PerfecTemp system

Active Comparator group

Description:

Patients will be warmed during surgery with the PerfecTemp heated pad .

Treatment:

Device: heated pad