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Temperature Management System

Temperature Management Systems for Preventing Intraoperative Hypothermia

N/A

Waitlist Available

Research Sponsored by Tampa General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Patients with a history of bleeding disorders

Pregnant patients; all female patients of childbearing age will be given a pregnancy test on the day of surgery

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to compare two temperature management systems, warmUP and Bair Hugger®, to see if warmUP is as effective as Bair Hugger® in preventing low body temperature during surgeries.

Who is the study for?

This trial is for patients undergoing abdominal surgeries expected to last around 2.5 hours, who need temperature management to prevent hypothermia during the operation.

What is being tested?

The study compares two devices: the warmUP Sleeve and Bair Hugger®. It checks if warmUP can maintain body temperature as effectively as Bair Hugger®, with potential benefits like reduced bacterial spread.

What are the potential side effects?

While not explicitly mentioned, side effects may include skin irritation or burns from improper use of warming devices, and potential discomfort associated with wearing these systems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old and scheduled for a 2-4 hour elective abdominal surgery under general anesthesia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of bleeding disorders.

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I will take a pregnancy test on the day of my surgery if I am of childbearing age.

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I have a break in the skin where the treatment will be applied.

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I am either younger than 18 or older than 80.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ recorded every 15 minutes from the start of administration of general anesthesia through end of administration of anesthesia; typically 4-5 hours.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~recorded every 15 minutes from the start of administration of general anesthesia through end of administration of anesthesia; typically 4-5 hours.

This trial's timeline: 3 weeks for screening, Varies for treatment, and recorded every 15 minutes from the start of administration of general anesthesia through end of administration of anesthesia; typically 4-5 hours. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Continuing Temperature trends

Initial Temperature

Post-operative temperature

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AVACore Technologies, Inc. warmUP SleeveExperimental Treatment2 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.

0 / 5Eligibility criteria met