Warming Devices for Preventing Heat Loss

DS
FR
Overseen ByFabio Rodriguez, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cleveland Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of different warming devices and blankets in preventing heat loss. Volunteers will use various full-body blankets connected to different warming systems to determine which combination best maintains stable body temperature. Ideal participants are healthy individuals with a body mass index (BMI) between 20 and 33, without serious skin conditions or vascular issues such as Raynaud's Syndrome. As an unphased trial, this study allows participants to contribute to innovative research that could enhance patient care in the future.

Do I need to stop my current medications for the trial?

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

What prior data suggests that these warming devices and blankets are safe for preventing heat loss?

Research has shown that full-body warming blankets are generally safe for use. For example, studies on the 3M™ Bair Hugger™ warming blankets found that they effectively transfer heat. They also feature foot drapes to reduce the risk of burns to sensitive areas like the feet and lower legs.

Similarly, Stryker Mistral-Air warming blankets safely manage body temperature. They deliver warm air quietly and efficiently without creating high pressure. These blankets keep patients comfortable and safe by creating a warm air layer around the body with gentle airflow.

Overall, these products have been used successfully to control body temperature without significant side effects, making them well-tolerated by most people.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to prevent heat loss using advanced warming devices. Unlike traditional methods, which may rely on simple blankets or heating pads, this trial examines high-tech full-body warming systems that integrate different types of blankets with specialized blowers. These systems are designed to provide consistent and controlled warming, potentially offering more effective and efficient heat retention. By testing various combinations of blankets and blowers, researchers hope to find the optimal setup for preventing heat loss, which could lead to improved patient comfort and outcomes in medical settings.

What evidence suggests that these warming devices and blankets are effective for preventing heat loss?

This trial will evaluate various full-body warming blankets, including the 3M Bair Hugger, known for its effectiveness in maintaining steady body temperature. The Bair Hugger uses warm air to envelop the entire body, helping to prevent hypothermia and maintain normothermia. Studies have found that this blanket provides consistent warmth by creating a gentle layer of warm air around the body. Another warming device tested in this trial is the FilteredFlo Air Blanket, which also creates a small, warm air environment to help prevent heat loss. These blankets are designed to keep participants warm and comfortable.24567

Who Is on the Research Team?

sS

sessled@ccf.org Sessler, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for healthy volunteers aged 18-40 with a body-mass index (BMI) between 20 and 33. Participants should be in good physical condition, classified as ASA Physical Status 1 or 2, which means they have no or only mild systemic disease.

Inclusion Criteria

I am healthy or have mild systemic disease.
My BMI is between 20 and 33.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are exposed to different warming devices and blankets in a crossover design to measure heat transfer and thermal comfort

5 sessions of 30 minutes each with 40-minute washout periods

Follow-up

Participants are monitored for any adverse effects and overall thermal comfort post-treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Full-Body Blanket
Trial Overview The study tests the effectiveness of four different warming devices connected to five types of full-body blankets in preventing heat loss. Volunteers will not be under anesthesia and will experience each blanket-device combination through random assignment.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: EADBCExperimental Treatment5 Interventions
Group II: DCAEBExperimental Treatment5 Interventions
Group III: CEBADExperimental Treatment5 Interventions
Group IV: BDECAExperimental Treatment5 Interventions
Group V: ABCDEExperimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

The Surgical Company

Collaborator

Trials
1
Recruited
20+

Citations

Heat Loss in Humans Covered With Full-Body Blankets ...Evaluate cutaneous heat loss/ gain using thermal flux transducers while volunteers are covered with the premium adult blanket, 3320 blanket connected to the ...
3M Bair Hugger Full Body Warming BlanketsThe Bair Hugger full-body blanket provides full coverage for the patient, maximizing thermal transfer; Foot drape minimizes the risk of thermal injury to ...
3M™ Bair Hugger™ Warming Blanket, 30000The 3M Bair Hugger is a single-use, full-body forced-air blanket that prevents hypothermia, maintains normothermia, and provides consistent, even warming.
WarmAir® & FilteredFloFilteredFlo air blankets transfer heat to the patient by using gentle, diffused air flow to effectively create a microclimate of warm air between the patient ...
3M Health Care 30000 Arizant Bair Hugger Model 300 ...This forced-air warming blanket provides coverage to the entire patient.
Heat Loss in Humans Covered With Full-Body Blankets ...After a 40-minute washout period, the volunteers will be covered with the adult blanket plus, MA2220 connected to the Mistral Air, Blower MA1200-PM system for ...
Stryker Mistral-Air Forced Air Warming BlanketsAssists with safe, simple and efficient management of patient body temperature; High-volume blower quietly delivers warm air through low-pressure blanket ...
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