What side effects are associated with this type of intervention?

Common treatments for fever include antipyretic medications such as acetaminophen and ibuprofen. Acetaminophen can cause side effects like liver damage, especially when used in high doses or in patients with pre-existing liver conditions. Ibuprofen may lead to gastrointestinal issues such as stomach pain, ulcers, and bleeding, as well as kidney problems with long-term use. In the context of patient warming systems, such as forced-air warming, side effects are generally minimal but can include discomfort from the heat, sweating, and rarely, burns if the device malfunctions. Overall, while antipyretics have more systemic side effects, patient warming systems primarily cause local discomfort.

What prior FDA approvals exist?

The FDA has approved various methods for managing fever and maintaining body temperature, including the use of forced-air warming systems like the Bair Hugger Blanket. These systems are designed to prevent perioperative hypothermia by warming intravenous and irrigation fluids, ensuring normothermia during surgical procedures. While specific drug approvals for fever management were not detailed, the focus on maintaining body temperature through such devices highlights their importance in clinical settings.

What other types of research exist?

One promising alternative to forced-air warming systems for maintaining body temperature in fever patients is the use of heated humidification systems. These systems, such as the Westmed system, have been evaluated for their efficacy in maintaining body temperature. Another potential alternative is the use of conductive warming blankets, which provide direct heat transfer and can be more efficient in certain clinical scenarios. Both methods offer viable options for patient temperature management in 2024.

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Device

Heated Systems for Maintaining Body Temperature in Pediatric Surgery (ANAPOD Trial)

N/A

Waitlist Available

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

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

Must have

Pediatric patients undergoing elective, scheduled dental procedures at Masonic Children's hospital requiring general anesthesia with endotracheal intubation, anticipated to last 1-6 hours or longer

Be younger than 65 years old

Must not have

Patients that will not be intubated for the procedure

History of diseases associated with temperature dysregulation (active hyperthyroidism, dysautonomia, osteogenesis imperfecta, history of malignant hyperthermia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study visit 1, at conclusion of dental procedure/anesthesia administration, approximately 1-6 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two methods to keep patients warm during surgery: the Westmed system, which uses warm, moist air through a breathing tube, and the Bair Hugger Blanket, which blows warm air over the body. It focuses on patients under general anesthesia who are at risk of getting too cold.

Who is the study for?

This trial is for pediatric patients who need general anesthesia with endotracheal intubation for dental procedures expected to last between 1-6 hours at Masonic Children's Hospital. It's not suitable for those with temperature regulation diseases, a history of malignant hyperthermia, or if additional non-dental procedures are planned.

What is being tested?

The study compares the effectiveness of two methods to maintain body temperature during surgery: the Anapod™ Humi-Therm Heated Humidification System Breathing Circuit and the Bair Hugger™ Warming Blanket.

What are the potential side effects?

Potential side effects may include skin irritation from contact with devices, possible burns if equipment malfunctions, and discomfort due to prolonged use of warming devices.

Eligibility Criteria

Inclusion Criteria

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

Select...

My child is scheduled for a dental procedure under general anesthesia expected to last 1-6 hours or more.

Exclusion Criteria

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

Select...

I will not be put on a breathing machine for my procedure.

Select...

I have a history of conditions affecting my body's temperature regulation.

Select...

My parents have not agreed to the treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study visit 1, at conclusion of dental procedure/anesthesia administration, approximately 1-6 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study visit 1, at conclusion of dental procedure/anesthesia administration, approximately 1-6 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and study visit 1, at conclusion of dental procedure/anesthesia administration, approximately 1-6 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

Rectal Temperature

Secondary study objectives

Cumulative degree-minutes above and below 37C

Need for Hyperthermic or Hypothermic Rescue

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Anapod™ Humi-Therm Heated Humidification SystemExperimental Treatment1 Intervention

Patient warming will be provided via the Anapod™ Humi-Therm Heated Humidification System Breathing Circuit.

Group II: Bair Hugger™ Warming BlanketActive Control1 Intervention

Patient warming will be provided via the Bair Hugger™ Warming Blanket.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anapod™ Humi-Therm Heated Humidification System Breathing Circuit

2019

N/A

~100

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for fever include antipyretics like acetaminophen and ibuprofen, which lower body temperature by inhibiting prostaglandin production in the brain, thus resetting the hypothalamic set point. Physical methods, such as forced-air warming systems, are also used to maintain normothermia by providing external heat. These treatments are crucial for fever patients as they help manage body temperature, prevent complications like hypothermia, and support overall recovery.

Warming of intravenous and irrigation fluids for preventing inadvertent perioperative hypothermia.