Temperature Management Systems for Preventing Intraoperative Hypothermia

Overseen By Enrico M Camporesi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tampa General Hospital

Disqualifiers: Pregnancy, Allergic skin conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2.5 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two devices, the warmUP and the Bair Hugger®, to evaluate their effectiveness in keeping patients warm during abdominal surgeries. The researchers aim to determine if the warmUP maintains body temperature as effectively as the Bair Hugger® and if it helps reduce bacterial spread. Participants will use one of these devices during surgeries lasting about 2.5 hours, with their body temperatures monitored. This trial is for individuals undergoing elective abdominal surgery under general anesthesia, who have no skin issues or history of conditions like allergic skin conditions or bleeding disorders. As an unphased trial, it offers participants the chance to contribute to research that could enhance surgical outcomes and patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these temperature management systems are safe for preventing intraoperative hypothermia?

Research has shown that the warmUP system has been safely used in people before. In the mid-2000s, over 100 patients in the U.S. used an earlier version of this system. The FDA has approved the warmUP system, indicating it has passed safety checks for its intended use.

Another option is the Bair Hugger® system, commonly used in surgeries to keep patients warm. It effectively prevents hypothermia, which occurs when body temperature drops too low during surgery. Both systems are non-invasive, meaning they do not require surgery or entering the body, and patients generally tolerate them well.

Overall, existing evidence suggests that both the warmUP and Bair Hugger® systems are safe options for maintaining stable body temperature during surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the warmUP Sleeve for preventing intraoperative hypothermia because it offers a unique approach compared to traditional warming blankets. Unlike conventional methods that rely solely on external heat, the warmUP Sleeve combines heat with vacuum technology to enhance blood flow and heat distribution. This innovative mechanism has shown a potential rewarming rate of about 1ºC in just 5 minutes, which is significantly faster than standard practices. Such rapid effectiveness could provide better patient outcomes during surgeries by minimizing the risk of hypothermia.

What evidence suggests that these temperature management systems are effective for preventing intraoperative hypothermia?

Research has shown that active warming methods, such as the warmUP system, can help maintain steady body temperature during surgery. Patients who used similar warming systems in the past warmed up by about 1°C in just 5 minutes. The warmUP system controls body temperature while covering less skin, potentially reducing infection risk. The Bair Hugger® is another treatment option in this trial and is a well-known and trusted method for stabilizing body temperature during surgery. Both systems work to prevent hypothermia, a condition where body temperature drops too low during an operation. Additionally, the warmUP system might help reduce the spread of bacteria. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

Patients with a history of allergic skin conditions

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

Patients with a history of malignant hyperthermia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo abdominal surgeries using either the warmUP or Bair Hugger® system to maintain intraoperative body temperature

2.5 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including temperature monitoring in the PACU

5 minutes after PACU admission

Post-operative Monitoring

Comparison of body temperature trends and hypothermic symptoms such as shivering

60 minutes after induction of general anesthesia

What Are the Treatments Tested in This Trial?

Interventions

• Bair Hugger
• warmUP

Trial Overview 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.

How Is the Trial Designed?

Group I: AVACore Technologies, Inc. warmUP Sleeve Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Tampa General Hospital

Lead Sponsor

Trials

22

Recruited

4,400+

TeamHealth

Collaborator

Trials

1

Recruited

30+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06597214

Intraoperative Warming: Comparison of Two Temperature ... The study will evaluate whether the warmUP system provides equivalent temperature management with a smaller body surface area exposed, potentially offering ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12161556/

The optimal warming strategy to reduce perioperative ... In this study, we compared the effectiveness of four warming strategies by measuring the degree of intraoperative hypothermia experienced by ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0748798325007577

Effectiveness of active warming interventions in preventing ... Our findings indicate that the use of active warming techniques during cancer surgery significantly reduces intraoperative core body temperature loss, ...

4. bmcsurg.biomedcentral.com bmcsurg.biomedcentral.com/articles/10.1186/s12893-024-02729-0

Strategies for perioperative hypothermia management This narrative review discusses in detail the currently common warming strategies for perioperative hypothermia.

5. cureus.com cureus.com/articles/86541-preoperative-forced-air-warming-strategy-is-it-effective-in-averting-intraoperative-hypothermia-in-elderly-trauma-surgical-patients

Preoperative Forced-Air Warming Strategy: Is It Effective in ... A preoperative forced-air warming strategy for 30 minutes helps in reducing the incidence of intraoperative hypothermia and shivering in elderly patients.

6. avacore.com avacore.com/products

Products FDA cleared, non-invasive, fluid-based patient warming system to maintain normothermia without the risk of forced-air contamination.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11684272/

Strategies for perioperative hypothermia management While FAW systems are widely recognized as effective for perioperative hypothermia prevention, certain limitations have been identified. A 2015 ...

8. ohsu.edu ohsu.edu/sites/default/files/2021-07/Evidence%20Brief%20on%20Forced%20Air%20Warming%20Devices%20for%20Surgical%20Use.pdf

Evidence Brief on Forced Air Warming Devices for Surgical ... 1 Forced-air warming (FAW) represents one of the most widely used methods to prevent hypothermia and maintain intraoperative normothermia.

9. researchgate.net researchgate.net/publication/355870969_Value_of_Active_Warming_Devices_for_Intraoperative_Hypothermia_Prevention-A_Meta-Analysis_and_Cost-Benefit_Analysis

(PDF) Value of Active Warming Devices for Intraoperative ... The purpose of this study is to estimate the value of active warming devices for IH prevention based on synthesized evidence. Methods: A cost- ...