Phase 3
N=55
Comparison of Intraoperative Warming Devices
Total Knee Arthroplasty
Bottom Line
View on ClinicalTrials.gov: NCT00711867 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Dec 2009
Primary outcome: Primary: Sublingual Temperature. — 36.38; 36.73 C
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- VH2 (Device); Bair Hugger (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sublingual Temperature. |
36.38; 36.73 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00711867). 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.