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

NCT ID: NCT01075724

Last Updated: 2015-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-07-31

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).

Detailed Description

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Conditions

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Hypothermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Forced air

Forced Air Warming

Group Type ACTIVE_COMPARATOR

Patient Warming with Forced Air

Intervention Type DEVICE

Forced Air warming via BairHugger

Resistive HotDog Warming

Warming by resistive Warming

Group Type EXPERIMENTAL

Resistive Warming

Intervention Type DEVICE

Resistive Warming via HotDog device

Interventions

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Patient Warming with Forced Air

Forced Air warming via BairHugger

Intervention Type DEVICE

Resistive Warming

Resistive Warming via HotDog device

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Oliver Kimberger

Assoc.Prof.PD Dr. MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oliver Kimberger

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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HDBH3

Identifier Type: -

Identifier Source: org_study_id

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