Comparison Study of Intraoperative Patient Warming Systems
|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|
|Orthopedic Surgery General Anesthesia||Device: vitalHEAT vH2 Temperature Management System Device: Arizant Healthcare Bair Hugger Temperature Management System|
|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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670826
|Contact: Kent P Weinmeister, MDemail@example.com|
|United States, Arizona|
|Mayo Clinic Hospital|
|Phoenix, Arizona, United States, 85054|
|Principal Investigator:||Kent P Weinmeister, MD||Mayo Clinic|