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临床试验/NCT01176110
NCT01176110已完成不适用

A Randomized Pilot Study for Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Temperature at the end of the intervention

研究概览

简要总结

It is known that perioperative hypothermia can influence the postoperative outcome negatively.

The most important complications are cardiac, increased blood loss with need for transfusion and a significantly increased wound infection rate.

The thermal redistribution after the induction of anesthesia is on of the reasons for perioperative hypothermia. Another reason is negative heat balance during surgery.

Further negative side effects of hypothermia are an increase of blood viscosity and thus a higher risk for thrombosis, coagulopathy and thus an increased risk of bleeding.

The aim of the study is to evaluate if patients with a perioperative active thermal management during an interventional minimal invasive valve replacement have a significantly higher body temperature at the end of the operation than patients without an active thermal management. Secondary outcome variables are complication rates, length of mechanical ventilation and length of ICU treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • Patients, who need an interventional minimal invasive valve replacement
  • Age ≥ 18 years
  • scheduled general anesthesia during intervention
  • no participation on another interventional study
  • signed informed consent

排除标准

  • pregnant or breast feeding women
  • non-elective intervention
  • conversion to HLM
  • implantation of IABP
  • pre-existing decubitus
  • patients who are not able to sign informed consent

结局指标

主要结局

Temperature at the end of the intervention

时间窗: average 2 hours

The end of the surgical procedure is defined and is recorded for all patients in the hospital information systems. This time point will be used to record the body temperature at the end of the intervention

次要结局

  • hospital stay(max 28 days)
  • mechanical ventilation time(maximum 28 days)

研究者

申办方类型
Other

研究点 (2)

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