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Sponsored by: |
Dynatherm Medical Inc. |
Information provided by: | Dynatherm Medical Inc. |
ClinicalTrials.gov Identifier: | NCT00670826 |
Medications used to put people to sleep during surgical procedures also cause changes in the body's ability to control its temperature. These changes can make a person's temperature drop below normal. To minimize this drop in body temperature, different types of body warming products are used during surgery. This study is designed to compare the the temperatures of people under general anesthesia after 60 minutes of warming with each product. The study hypothesis is that the people warmed with the Dynatherm Medical vitalHEAT vH2 System will decrease less in the first 60 minutes of warming time than people warmed with the Arizant Bair Hugger System.
Condition | Intervention |
Orthopedic Surgery General Anesthesia |
Device: vitalHEAT vH2 Temperature Management System Device: Arizant Healthcare Bair Hugger Temperature Management System |
MedlinePlus related topics: | Anesthesia |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHEAT Temperature Management System(vH2)With the Arizant Bair Hugger System |
Estimated Enrollment: | 100 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Use of the Dynatherm Medical vitalHEAT vH2 Temperature Management System to warm patients undergoing orthopedic surgical procedures with an expected duration 2-3 hours and requiring general anesthesia.
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Device: vitalHEAT vH2 Temperature Management System
The vH2 system utilizes a combination of localized heat and vacuum application to one hand & forearm; this application opens AVAs in the palm of the hand and warms the extremity thus effectively warming the blood flowing to the body's core.
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2: Active Comparator
Use of the Arizant Healthcare Bair Hugger Temperature Management System & Bair Hugger Upper Body Blanket to warm patients undergoing orthopedic surgical procedures with an expected duration 2-3 hours and requiring general anesthesia.
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Device: Arizant Healthcare Bair Hugger Temperature Management System
The Bair Hugger system is a forced air system providing convective warming via the circulation of warmed air through specially designed blanket which is placed over a portion of the body
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kent P Weinmeister, MD | 480-342-2446 | weinmeister.kent@mayo.edu |
United States, Arizona | |||||
Mayo Clinic Hospital | |||||
Phoenix, Arizona, United States, 85054 | |||||
Contact: Mary B Laney, CRNA 480-515-6296 ext 73209 laney.mary@mayo.edu |
Dynatherm Medical Inc. |
Principal Investigator: | Kent P Weinmeister, MD | Mayo Clinic Scottsdale |
Responsible Party: | Mayo Clinic Scottsdale ( Kent Weinmeister, MD ) |
Study ID Numbers: | M100 IRB07-003313, TP0010C |
First Received: | April 29, 2008 |
Last Updated: | May 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00670826 |
Health Authority: | United States: Institutional Review Board |
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