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临床试验/NCT02353793
NCT02353793已完成不适用

Trauma Patients and Hypothermia in the Emergency Room: a Trial Between Self-warming ReadyHeat® Blanket and Traditional Cotton Wool Blanket

University Hospital Schleswig-Holstein2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Body core temperature at the end of completed emergency room treatment

研究概览

简要总结

Hypothermia is a common problem in traumatized patients leading to severe complications such as impaired coagulation, increased rate of wound infections and overall patient discomfort among others. Therefore, the investigators test out the new self warming ReadyHeat® blanket device against the currently used cotton wool blanket in terms of effects on the prevention and treatment of hypothermia.

详细描述

Hypothermia is a common problem in traumatized patients leading to severe complications such as impaired coagulation, increased rate of wound infections and overall patient discomfort among others. Therefore, the investigators test out the new self warming (via an exothermic reaction) ReadyHeat® blanket device against the currently used cotton wool blanket in terms of effects on the prevention and treatment of hypothermia. Near body core temperature is measured by a sublingual sensor as the "gold standard" of body core temperature measurement - the pulmonary artery catheter - is too invasive and not suited for this collective of patients in the emergency room setting. Blanket use will be randomized. Temperature will be taken at emergency room admission, after 15, 30 and 45 minutes of treatment as well as right before handing the patient over to the next caring unit (ICU, IMC, operating theatre etc.). If treatment time is shorter than expected measurement will stop at the latest possible point. Blankets will be applied to the patient once admission in the emergency room is complete and will only be lifted for interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Trauma patients ≥ 18 years of all severity stages including poly traumatized patients admissioned through the emergency room

排除标准

  • Patients < 18 years
  • Patients after pre-hospital cardiac arrest or ongoing CPR at time of admission

结局指标

主要结局

Body core temperature at the end of completed emergency room treatment

时间窗: When handing the patient over to the next caring unit (ICU, operating theatre etc.) n most cases an average time frame < 60 min is maintained

Body core temperature taken after completed emergency room treatment incl. imaging. In most cases an average time frame \< 60 min is maintained.

次要结局

  • Body core temperature during emergency room treatment(Temperature measurement: Admission, after 15, 30, 45 minutes)

研究者

发起方
University Hospital Schleswig-Holstein
申办方类型
Other
责任方
Principal Investigator
主要研究者

Timo Iden

M.D.

University Hospital Schleswig-Holstein

研究点 (2)

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