A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Cleveland Clinic
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Time Weighted Average Core Temperature
Study Overview
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 Frame: 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 Outcomes
- Proportion of Patients With Temperatures Above 36 Degree(at the end of surgery)
Investigators
d sessler
Principal Investigator
The Cleveland Clinic