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