At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intraoperative Warming: Comparison of Performance of the AVAcore Technologies warmUP™ Temperature Management System (WU-20) and the Arizant Bair Hugger Temperature Management System
In Brief
A clinical study evaluating AVACore Technologies, Inc. warmUP Sleeve and Arizant Healthcare Bair Hugger® for Normothermia and 2 related conditions. Completed, enrolled 90 participants across 1 site.
Detailed Summary
The goal of this clinical trial is to compare two temperature management systems, the warmUP (WU-20) and the Bair Hugger®, in preventing perioperative hypothermia during surgeries. The study aims to determine whether the warmUP system is as effective as the Bair Hugger® in maintaining core body temperature. The main questions this trial aims to answer are: Does the warmUP system maintain intraoperative body temperatures as effectively as the Bair Hugger® during abdominal surgeries? Does the warmUP system offer additional benefits, such as reduced bacterial dispersion compared to the Bair Hugger®? Participants will: Use either the warmUP or Bair Hugger® system during surgery Undergo abdominal surgeries lasting approximately 2.5 hours Have their core temperatures monitored to assess the effectiveness of the warming device The study will evaluate whether the warmUP system provides equivalent temperature management with a smaller body surface area exposed, potentially offering advantages in surgical infection control.
Study Details
Timeline
Interventions
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.
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.