Comparison Study of Intraoperative Patient Warming Systems
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|ClinicalTrials.gov Identifier: NCT00670826|
Recruitment Status : Unknown
Verified April 2008 by Dynatherm Medical Inc..
Recruitment status was: Not yet recruiting
First Posted : May 2, 2008
Last Update Posted : May 2, 2008
|Condition or disease||Intervention/treatment||Phase|
|Orthopedic Surgery General Anesthesia||Device: vitalHEAT vH2 Temperature Management System Device: Arizant Healthcare Bair Hugger Temperature Management System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHEAT Temperature Management System(vH2)With the Arizant Bair Hugger System|
|Study Start Date :||July 2008|
|Estimated Primary Completion Date :||September 2008|
|Estimated Study Completion Date :||November 2008|
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.
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.
Active Comparator: 2
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.
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
- Compare esophageal temperatures after 60 minutes of warming with each system [ Time Frame: 60 minutes of patient warming ]
- Compare esophageal temperature trends during surgical procedures [ Time Frame: Every 15 minutes during procedure ]
- Compare sublingual temperatures of patients in PACU [ Time Frame: Within 10 minutes of arrival in PACU ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670826
|Contact: Kent P Weinmeister, MDfirstname.lastname@example.org|
|United States, Arizona|
|Mayo Clinic Hospital|
|Phoenix, Arizona, United States, 85054|
|Principal Investigator:||Kent P Weinmeister, MD||Mayo Clinic|