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OpenTrials
Completed

NCT Number: NCT00711867

Comparison of Intraoperative Warming Devices

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.

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Key information

Conditions

Total Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic

Phoenix, Arizona, 85054, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VH2

Device

Dynatherm vitalHeat2 (VH2) temperature management system.

Bair Hugger

Device

Arizant Bair Hugger temperature management system.

Primary outcomes

  1. Sublingual Temperature.

    Time frame: Within 10 minutes of arrival in PACU

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Dynatherm Medical Inc.

Registry information

Official study title

Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHeat™ Temperature Management System (vH2) and the Arizant Bair Hugger System

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 9, 2008
Registry last updated
Dec 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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