90
Participants
Start Date
June 1, 2023
Primary Completion Date
May 15, 2025
Study Completion Date
May 15, 2025
AVACore Technologies, Inc. warmUP Sleeve
AVAcore Technologies's warmUP (WU-20) Temperature Management System was developed based on work with the Aquarius Medical Acrotherm device and prior human hypothermic subject data showing a rewarming rate of \~1ºC in 5 minutes when heat and vacuum application was tested. AVAcore Technologies received FDA acceptance of its Section 510(k) premarket notification for the warmUP (vH1) Temperature Management System in 2005. This product was used on over 100 patients in the US in 2005-2006 timeframe.
Arizant Healthcare Bair Hugger®
The Arizant Healthcare Bair Hugger® Temperature Management System proposed for use in this study is a 'forced air' system providing convective warming via the circulation of warmed air through a specially designed blanket which is placed over a portion of the patient's body. This product has been in use in the US for over 20 years in a majority of hospitals.
Tampa General Hospital, Tampa
TeamHealth
UNKNOWN
Tampa General Hospital
OTHER