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Comparison of Intraoperative Warming Devices

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00711867
First Posted: July 9, 2008
Last Update Posted: December 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dynatherm Medical Inc.
Information provided by:
Mayo Clinic
  Purpose
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kent Weinmeister M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00711867     History of Changes
Other Study ID Numbers: 07-003313
First Submitted: July 7, 2008
First Posted: July 9, 2008
Results First Submitted: October 28, 2009
Results First Posted: December 2, 2009
Last Update Posted: December 15, 2009
Last Verified: December 2009