Cerebral Perfusion During Cardiac Surgery With Hypothermic Circulatory Arrest
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
- TOI
研究概览
简要总结
Selective antegrade cerebral perfusion (sACP) during aortic arch surgery in hypothermic circulatory arrest (HCA) is an established method for intraoperative neuroprotection. Although sACP is established as a beneficial method to reduce secondary neurological side effects due to brain-malperfusion, there are several parameters like sACP flow rate, perfusion pressure or temperature of the perfusate, where the optimal values remain unclear. The flow rate of the sACP-perfusate is increased according to center-specific standard-procedures. The optimal sACP flow rate, monitored by near infrared spectroscopy (NIRS), is to be investigated in this single center clinical prospective observational study. 40 Patients are enrolled over an estimated period of 14 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 years or older
- •Elective cardiac surgery with cardiopulmonary bypass
- •Hypothermic circulatory arrest
- •General informed consent signed
排除标准
- •Severe stenotis in cerebral arteries
结局指标
主要结局
TOI
时间窗: through study completion, an average of 1 year
The primary outcome is the tissue oxygenation index (TOI: NIRS value) at sACP flow rates of 6 , 8 and 10 (ml/kg/min) in comparison to the TOI measured awake.
次要结局
- Vmca(through study completion, an average of 1 year)
- Neurologic accidents(through study completion, an average of 1 year)
研究者
Gabor Erdös
Consultant
Insel Gruppe AG, University Hospital Bern