Comparison of a New Patient Warming System Using a Polymer Conductive Warming Under-body and Upper-body Blanket With Forced Air Warming

Study Overview
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Brief Summary
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Intraoperative active warming is usually performed by skin warming. There are several forced-air systems on the market; forced air warming is generally described as the most effective yet feasible method of patient warming. Augustine Biomedical (Eden Prairie, MN, USA) recently introduced a new patient warming system named Hot Dog with an active polymer warming upper-body blanket and a new under-body warming mattress. The polymer-heating devices consist of an electronic regulator and the polymer blankets, which are covered with a washable fabric. Conventional mains power the system. The manufacturer claims, that the new system Hot Dog (with combination of under body and upper body warming) is as effective as forced air warming, while not having any disadvantages of the forced air system, like: airborne infection, noise, high power consumption and hard-to-clean hose. The investigators will compare the new Hot Dog patient warming device combination (under body + upper body) with the established warming system, which blows warm air via a mattress over the body of the patients).

Official Title
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Comparison of a New Patient Warming System Using a Polymer Conductive Warming Under-body and Upper-body Blanket With Forced Air Warming During Surgery

Conditions
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Hypothermia

Intervention / Treatment
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* Device: Patient Warming with Forced Air
* Device: Resistive Warming


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The investigators will study 40 patients (18-90 years) undergoing elective orthopedic lower limb surgery at the trauma surgery unit. The patients must have normal weight (20-30 BMI), the duration of surgery should last between 2 - 3 hours. Exclusion Criteria: There will be no other exclusion criteria (except severe peripheral arterial disease in the warmed extremity), as forced air patient warming is routinely used for all patients during this procedure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Forced air<br>Forced Air Warming | Device: Patient Warming with Forced Air<br>* Forced Air warming via BairHugger<br>|
| Experimental: Resistive HotDog Warming<br>Warming by resistive Warming | Device: Resistive Warming<br>* Resistive Warming via HotDog device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Core Temperature at the end of surgery (at time of skin suture) |  | Single Measurement at Beginning of Skin Suture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Core temperature increase (°C/time) |  | From Beginning until End of Surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perioperative Hypothermia Prevention, Accidental Perioperative Hypothermia