Comparison of Intraoperative Warming Devices

Phase 3

Completed

• Conditions: Total Knee Arthroplasty
• Interventions: Device: VH2; Device: Bair Hugger

• Registration Number: NCT00711867
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-08
• Study First Posted: 2008-07-09
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2009-10-28
• Results First Submitted QC: 2009-10-28
• Status Verified: 2009-12
• Results First Posted: 2009-12-02
• Last Update Submitted: 2009-12-09
• Last Update Posted: 2009-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VH2	VH2	Dynatherm vitalHeat2 (VH2) temperature management system.
Bair Hugger	Bair Hugger	Arizant Bair Hugger temperature management system.

Primary Outcome Measures

Name	Time	Method
Sublingual Temperature.	Within 10 minutes of arrival in PACU

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States