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Intraoperative Warming: Comparison of Two Temperature Management Systems

NCT06597214 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-06-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • TeamHealth

    collaborator UNKNOWN

  • Tampa General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-05-15
Completion
2025-05-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06597214 on ClinicalTrials.gov