跳至主要内容
临床试验/NCT01075724
NCT01075724已完成3 期

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

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年1月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Core Temperature at the end of surgery (at time of skin suture)

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Forced air

Active Comparator

Forced Air Warming

干预措施: Patient Warming with Forced Air (Device)

Resistive HotDog Warming

Experimental

Warming by resistive Warming

干预措施: Resistive Warming (Device)

结局指标

主要结局

Core Temperature at the end of surgery (at time of skin suture)

时间窗: Single Measurement at Beginning of Skin Suture

次要结局

  • Core temperature increase (°C/time)(From Beginning until End of Surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Oliver Kimberger

Assoc.Prof.PD Dr. MSc

Medical University of Vienna

研究点 (1)

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