Status:

COMPLETED

Comparison of Intraoperative Warming Devices

Lead Sponsor:

Mayo Clinic

Collaborating Sponsors:

Dynatherm Medical Inc.

Conditions:

Total Knee Arthroplasty

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 ane...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

July 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2008

Estimated Enrollment :

55 Patients enrolled

Trial Details

Trial ID

NCT00711867

Start Date

July 1 2008

End Date

December 1 2008

Last Update

December 15 2009

Active Locations (1)

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Mayo Clinic

Phoenix, Arizona, United States, 85054