Comparison Study of Intraoperative Patient Warming Systems
Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHEAT Temperature Management System(vH2)With the Arizant Bair Hugger System
Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHEAT Temperature Management System(vH2)With the Arizant Bair Hugger System
Sponsor study identifier
Secondary identifiers
interventional
100
1 country
1
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2008
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2008
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2008
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 29, 2008
Actual (reported)May 2, 2008
Actual (reported)July 2008
Date type not reportedThis date has not been verified as actual or estimated.
September 2008
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2008
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Compare esophageal temperatures after 60 minutes of warming with each system
60 minutes of patient warming
Compare esophageal temperature trends during surgical procedures
Every 15 minutes during procedure
Compare sublingual temperatures of patients in PACU
Within 10 minutes of arrival in PACU
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.
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.
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.
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
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Kent P Weinmeister, MD
Mayo Clinic
First Submitted
April 29, 2008
First Posted
May 2, 2008
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2008
Estimated (date passed)Vasodilation Effect of Inhalational Anesthetics
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2008
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 2, 2008
Record last verified: 2008-04
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