Comparison of Intraoperative Warming Devices

Mayo Clinic

Status and phase: Completed; Phase 3

Conditions: Total Knee Arthroplasty

Treatments: Device: VH2; Device: Bair Hugger

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00711867

07-003313

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

VH2

Experimental group

Description:

Dynatherm vitalHeat2 (VH2) temperature management system.

Treatment:

Device: VH2

Bair Hugger

Active Comparator group

Description:

Arizant Bair Hugger temperature management system.

Treatment:

Device: Bair Hugger