Comparison of Intraoperative Warming Devices

December 9, 2009 updated by: Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sublingual Temperature.
Time Frame: Within 10 minutes of arrival in PACU
Within 10 minutes of arrival in PACU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Dynatherm Medical Inc.

Investigators

  • Principal Investigator: Kent Weinmeister, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 7, 2008

First Submitted That Met QC Criteria

July 8, 2008

First Posted (Estimate)

July 9, 2008

Study Record Updates

Last Update Posted (Estimate)

December 15, 2009

Last Update Submitted That Met QC Criteria

December 9, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • 07-003313

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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