Near Infrared Spectroscopy in Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Cerebral oxygen desaturation during the "rapid pacing" period and periprocedural
研究概览
简要总结
Transcatheter aortic valve implantation (TAVI) is an alternative for patients, that are considered to be too sick for conventional aortic valve replacement. There is no conclusive opinion about the best anesthesiologic management of these patients. Sedation and general anaesthesia are both adequate and the current literature shows no benefit towards one of these methods.
This study wants to investigate the influence of these two anesthesiologic managements on the cerebral oxygen saturation during the "rapid pacing"-period during valvuloplasty. The patients are randomised allocated to one of these two anaesthesiological managements. The investigators use the Near-Infrared Spectroscopy (NIRS) to measure the cerebral oxygen saturation. Parallel there will be a measurement of cerebral biomarkers to monitor cerebral hypoxia.
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
- 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
- •informed consent
- •transcatheter aortic valve implantation
排除标准
- •denial by patient
- •denial by screening anaesthesist
- •active neurodegenerative disease
结局指标
主要结局
Cerebral oxygen desaturation during the "rapid pacing" period and periprocedural
时间窗: up to 48 hours
Biomarkers for cerebral ischemia will be measured up to 48 hours
次要结局
未报告次要终点
研究者
N Patrick Mayr
MD
Deutsches Herzzentrum Muenchen