Intraoperative Warming: Comparison of Two Temperature Management Systems

NACompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

May 15, 2025

Study Completion Date

May 15, 2025

Conditions
NormothermiaIntraoperative TemperatureAnesthesia
Interventions
DEVICE

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.

DEVICE

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.

Trial Locations (1)

33606

Tampa General Hospital, Tampa

All Listed Sponsors
collaborator

TeamHealth

UNKNOWN

lead

Tampa General Hospital

OTHER

NCT06597214 - Intraoperative Warming: Comparison of Two Temperature Management Systems | Biotech Hunter | Biotech Hunter