Non-invasive Monitoring of Cerebral Autoregulation in Perioperative Neonatal Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- determine the association between time spent outside individually determined cerebral autoregulation limits and the development of brain lesions suggestive of low brain output.
研究概览
简要总结
Cardiac surgery under extracorporeal circulation (ECC) in newborns with congenital heart disease causes significant morbidity and mortality. The perioperative period is a period of major vulnerability implicated in the appearance of these sequelae, and it is therefore essential to monitor brain function during ECC. The quality of cerebral oxygenation in the perioperative period is routinely monitored non-invasively by infra-red spectroscopy, which makes it possible to estimate cerebral tissue oximetry from a surface electrode (NIRS). The association between time spent outside the limits of cerebral autoregulation and the occurrence of perioperative encephalopathy is not known. The purpose of this study is to determine whether disturbances in brain autoregulation during the operative period are associated with the occurrence of postoperative encephalopathy in children operated on for congenital heart disease in the neonatal period. The main objective of the research is to determine the association between time spent outside individually determined cerebral autoregulation limits and the appearance of brain lesions suggestive of low brain output. Secondary objectives will investigate the association between time spent outside autoregulatory limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria and will study factors predictive of the development of postoperative encephalopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any newborn (0-28 days) with congenital heart disease, hospitalized in the preoperative period at the Nantes University Hospital, for whom a decision is made to perform an operation under extracorporeal circulation, suitable to be transported for an MRI without risk, advice taken from the treating team.
排除标准
- •emergency cardiac surgery
- •Preoperative extracorporeal assistance
- •Preoperative intubation
- •Preoperative administration of inotropes
- •Pre-operative instability contra-indicating pre-operative MRI
- •Dependence on a pace maker contra-indicating MRI Imaging.
- •Parental consent refusal
- •Non-affiliation to a health security insurance
结局指标
主要结局
determine the association between time spent outside individually determined cerebral autoregulation limits and the development of brain lesions suggestive of low brain output.
时间窗: 6 weeks after cardiac surgery
duration of period outside cerebral autoregulation limits, Number, size and extent of new lesions on post-operative MRI. Patients will be classified into 2 categories according to whether or not there are new lesions on MRI. The lesions retained will be infarcts, white matter lesions and intraparenchymal hemorrhages, classified according to the Magnetic Resonance Imaging Abnormality Scoring System.
次要结局
- describe association between time spent outside autoregulation limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria.(6 weeks after cardiac surgery)
- describe predictive factors of postoperative encephalopathy(day 1 (cardiac surgery))