This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Comparison of Intraoperative Warming Devices

This study has been completed.
Dynatherm Medical Inc.
Information provided by:
Mayo Clinic Identifier:
First received: July 7, 2008
Last updated: December 9, 2009
Last verified: December 2009
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.

Condition Intervention Phase
Total Knee Arthroplasty Device: VH2 Device: Bair Hugger Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 ]

Enrollment: 55
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
Experimental: VH2
Dynatherm vitalHeat2 (VH2) temperature management system.
Device: VH2
Dynatherm vitalHeat2 (VH2) temperature management system.
Active Comparator: Bair Hugger
Arizant Bair Hugger temperature management system.
Device: Bair Hugger
Arizant Bair Hugger temperature management system.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00711867

United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
Sponsors and Collaborators
Mayo Clinic
Dynatherm Medical Inc.
Principal Investigator: Kent Weinmeister, M.D. Mayo Clinic
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kent Weinmeister M.D., Mayo Clinic Identifier: NCT00711867     History of Changes
Other Study ID Numbers: 07-003313
Study First Received: July 7, 2008
Results First Received: October 28, 2009
Last Updated: December 9, 2009 processed this record on September 21, 2017