Intraoperative Warming: Comparison of Two Temperature Management Systems

NCT06597214 | Completed FDA Device

• 1 other identifier: STUDY001814 Sleeve Blanket
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Normothermia; Intraoperative Temperature; Anesthesia

Keywords

Forced-air warmers; perioperative temperature management

Outcome Measures

Primary Outcomes (3)

• Initial Temperature

  Comparison of body temperature

  60 minutes after induction of general anesthesia]

• Continuing Temperature trends

  Comparison of body temperature throughout surgery

  Recorded every 15 minutes from the start of administration of general anesthesia through end of administration of anesthesia; typically 4-5 hours.

• Post-operative temperature

  Taking patient temperature whilst in recovery in the post-anesthesia care unit (PACU)

  5 minutes after PACU admission

Study Arms (1)

AVACore Technologies, Inc. warmUP Sleeve

EXPERIMENTAL

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: AVACore Technologies, Inc. warmUP Sleeve; Device: Arizant Healthcare Bair Hugger®

Interventions

AVACore Technologies, Inc. warmUP Sleeve DEVICE

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.

AVACore Technologies, Inc. warmUP Sleeve

Arizant Healthcare Bair Hugger® DEVICE

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.

Also known as: Historical Control Group

AVACore Technologies, Inc. warmUP Sleeve

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects ages 18-80 who are having elective open abdominal surgery from 2-4 hours and requiring general anesthesia.

You may not qualify if:

• Patients who are not between ages 18-80
• Patients who are pregnant; all female patients of childbearing age will be given a pregnancy test on the day of surgery.
• Patients who have a break in skin integrity on extremity selected as application site
• Patients who have a history of allergic skin conditions
• Patients who have a history of bleeding disorders
• Patients who have a history of malignant hyperthermia

Sponsors & Collaborators

• Tampa General Hospital: lead
• TeamHealth: collaborator

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Related Publications (3)

• Sessler DI. Mild perioperative hypothermia. N Engl J Med. 1997 Jun 12;336(24):1730-7. doi: 10.1056/NEJM199706123362407. No abstract available.

  PMID: 9180091 BACKGROUND

• Davis AJ, Bissonnette B. Thermal regulation and mild intraoperative hypothermia. Curr Opin Anaesthesiol. 1999 Jun;12(3):303-9. doi: 10.1097/00001503-199906000-00008.

  PMID: 17013328 BACKGROUND

• Sessler DI. Perioperative heat balance. Anesthesiology. 2000 Feb;92(2):578-96. doi: 10.1097/00000542-200002000-00042.

  PMID: 10691247 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Professor of Surgery

Model Details: Prospective single-group assignment compared to a standard control.

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: June 1, 2023
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)