Total Knee Arthroplasty Clinical Trial
Official title:
Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHeatâ„¢ Temperature Management System (vH2) and the Arizant Bair Hugger System
Verified date | December 2009 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The sublingual (under the tongue) core temperature within 10 minutes of arrival in the post anesthesia care unit (PACU) for patients warmed with the Dynatherm vitalHeat2 (VH2) System under general anesthesia for total knee arthroplasty will be equivalent to that of patients warmed with the Arizant Bair Hugger System.
Status | Completed |
Enrollment | 55 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Initial total knee arthroplasty. - Expected duration of surgery at least 2 hours. - General anesthesia. - American Society of Anesthesiologists (ASA) classification I-III. - Age >= 18 years. Exclusion Criteria: - Skin abrasion at the device application site. - History of peripheral vascular disease. - History of allergic skin conditions of the upper extremities. - History of malignant hyperthermia. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | Dynatherm Medical Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sublingual Temperature. | Within 10 minutes of arrival in PACU | No |
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