Monitoring Of REgional Cerebral Oxygenation (rcSO2 ) With Near INFrared SpectrOscopy (NIRS) During Non-cardiac Surgery in Preterms, Neonates and Infants in Addition to Standard Monitoring to Guide Intraoperative Management
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 40
- 主要终点
- Cerebral hypoxic burden
研究概览
简要总结
The brain is a very vulnerable organ, especially in premature babies, newborns and infants. However, during anesthesia, the oxygenation of the brain can only be monitored indirectly and insufficiently. Near-infrared spectroscopy (NIRS) is an established monitoring method in other areas (e.g., neonatology, cardiac anesthesia), which provides non-invasive information about the regional oxygen supply of the brain. The integration of this monitoring device into the anaesthesiological care for neonates and infants could reduce the risk of cerebral hypoxia. The planned study investigates whether the use of NIRS in anesthetized children up to 6 months can prevent or influence the occurrence of 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
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Expected duration of Anesthesia >45 minutes
- •Intervention/surgery in the operating room
排除标准
- •Impossibility to place cerebral NIRS sensor
- •Known cerebral pathology
- •Missing parental consent
- •Congenial cardiac condition with right to left shunt
- •Cardiac surgery
结局指标
主要结局
Cerebral hypoxic burden
时间窗: 1 day
Time under 65% cerebral oxygen saturation
次要结局
- Number of participants with Vasopressor or Inotrope administered(1 day)
- Number of participants with erythrocyte administration(1 day)
- Fraction of inspired oxygen(1 day)
- Fluid administration(1 day)
- Number of participants with Vasopressor or Inotrope administered(1 day)
- Number of participants with erythrocyte administration(1 day)
- Fraction of inspired oxygen(1 day)