N/A N=70 Randomized Single-blind Supportive Care

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

Warming Systems During Surgery

Bottom Line

View on ClinicalTrials.gov: NCT01094119 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Time Weighted Average Core Temperature — 36.11; 36.02 Degrees C

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: heated blanket (Device); heated pad (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Aug 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Time Weighted Average Core Temperature	36.11; 36.02	—
SECONDARY Proportion of Patients With Temperatures Above 36 Degree	30; 21	0.0069 sig

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01094119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.