Comparison of Intraoperative Warming Devices

This study has been completed.

First Received: July 7, 2008 Last Updated: May 6, 2009 History of Changes

Sponsors and Collaborators:	Mayo Clinic Dynatherm Medical Inc.
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00711867

Purpose

The sublingual core temperature within 10 minutes of arrival in the PACU for patients warmed with the Dynatherm vH2 System under general anesthesia for total knee arthroplasty will be equivalent to that of patients warmed with the Arizant Bair Hugger System.

Condition	Intervention	Phase
Total Knee Arthroplasty	Device: VH2 Device: Bear Hugger	Phase III

MedlinePlus related topics: Knee Replacement

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHeat™ Temperature Management System (vH2) and the Arizant Bair Hugger System

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Sublingual temperature. [ Time Frame: Within 10 minutes of arrival in PACU ] [ Designated as safety issue: No ]

Enrollment:	54
Study Start Date:	July 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
VH2: Experimental Dynatherm VH2 temperature management system.	Device: VH2 Dynatherm VH2 temperature management system.
Bear Hugger: Active Comparator Arizant Bear Hugger temperature management system.	Device: Bear Hugger Arizant Bear Hugger temperature management system.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Initial total knee arthroplasty.
Expected duration of surgery at least 2 hours.
General anesthesia.
ASA 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711867

Locations

United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054

Sponsors and Collaborators

Mayo Clinic

Dynatherm Medical Inc.

Investigators

Principal Investigator:

Kent Weinmeister, M.D.

Mayo Clinic

More Information

No publications provided

Responsible Party:	Mayo Clinic ( Kent Weinmeister M.D. )
Study ID Numbers:	07-003313
Study First Received:	July 7, 2008
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00711867 History of Changes
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 07, 2009