Arterial Hypotension and Regional Cerebral Oxygen Saturation During Major Abdominal Surgery. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Cerebral tissue oximetry
研究概览
简要总结
In this study investigators will explore the association between intraoperative arterial hypotension and cerebral oxygen saturation in patients scheduled for major abdominal surgery. Investigators will assign patients to control or interventional group. In this last group arterial hypotension will be avoided based on a HPI (Hypotension Predictive Index) protocol. In the control group arterial hypotension will be promptly treated according to hemodynamic variables.
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
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for abominal surgery
排除标准
- •Emergency surgery
- •end-stage renal disease
- •pregnancy
- •atrial fibrillation
- •previous cerebral ischaemia
- •central nervous system disorders
研究组 & 干预措施
prevention
investigator will prevent intraoperative arterial hypotension based on HPI index
干预措施: HPI (Device)
treatment
investigators will treat intraoperative arterial hypotension based on standard hemodynamic parameters
结局指标
主要结局
Cerebral tissue oximetry
时间窗: immediately after surgery
the difference among the two groups of the percentage value of the median value of Cerebral Oxygen Saturation measured by the near-nfrared spectroscopic technology (Foresight sensor)
次要结局
未报告次要终点
研究者
RUSSO ANDREA
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS