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Comparison of Intraoperative Warming Devices

This study has been completed.
Sponsor:
Collaborator:
Dynatherm Medical Inc.
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00711867
First received: July 7, 2008
Last updated: December 9, 2009
Last verified: December 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

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: 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

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.
  • 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
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 by Mayo Clinic

Additional 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
Study First Received: July 7, 2008
Results First Received: October 28, 2009
Last Updated: December 9, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 22, 2013