Status:
COMPLETED
Comparison of Vital HEAT (vH2) Temperature Management System to Upper-body Forced-air Warming
Lead Sponsor:
The Cleveland Clinic
Conditions:
Surgery
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The primary objective of this study is to determine if the intraoperative distal esophageal (core) temperature with vitalHEAT warming is non-inferior to upper-body forced-air warming in patients under...
Detailed Description
Participants will be randomized into one of two groups. Patients assigned to vitalHEAT warming will have the circulating-water sleeve applied to an arm that will not require intravenous access. An eso...
Eligibility Criteria
Inclusion
- Body-mass index 20-36 kg/m2;
- Age 18-75 yrs;
- ASA Physical Status 1-3.
Exclusion
- Patient requires an intravenous or arterial catheter distal to the elbow on both arms;
- Serious skin lesions on the hands or arms;
- History of serious vascular disease in the arms;
- Pre-operative fever;
- Contraindication to sevoflurane endotracheal anesthesia.
- Pre-existing neuropathy
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00815191
Start Date
January 1 2008
End Date
December 1 2008
Last Update
July 18 2016
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195