Temperature Management Systems for Preventing Intraoperative Hypothermia

Overseen ByEnrico M Camporesi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tampa General Hospital

Disqualifiers: Pregnancy, Allergic skin conditions, others

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

Trial Summary

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 data supports the effectiveness of the treatment Bair Hugger for preventing intraoperative hypothermia?

Research shows that the Bair Hugger system is effective in maintaining body temperature during surgery, as patients using it had higher temperatures compared to those using a warming blanket. Additionally, patients treated with the Bair Hugger were less likely to be hypothermic after surgery, leading to shorter recovery times.¹ ² ³ ⁴ ⁵

Is the Bair Hugger system safe for use in humans?

The Bair Hugger system has been used in studies involving patients undergoing surgery, and no safety issues were reported. It effectively maintains body temperature during surgery, which can help prevent complications associated with hypothermia.¹ ² ³ ⁴ ⁶

How does the Bair Hugger treatment prevent intraoperative hypothermia differently from other treatments?

The Bair Hugger treatment uses forced-air warming, which is more effective at maintaining body temperature during surgery compared to other methods like warming blankets or conductive warming systems. This system circulates warm air around the body, providing efficient heat conservation and reducing the risk of hypothermia during operations.¹ ² ³ ⁷ ⁸

What is the purpose of this trial?

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 deviceThe 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.

Eligibility Criteria

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

See 3 more

Timeline

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

Treatment Details

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.

Participant Groups

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.