Noninvasive Measurement of the Cerebral Autoregulation in Neonates and Infants With Complex Congenital Heart Disease After Cardiac Surgery With Cardiopulmonary Bypass at the Pediatric Intensive Care Unit (PICU)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Range of mean arterial blood pressure
研究概览
简要总结
Feasibility of non-invasive cerebral autoregulation measurement at the PICU and impact of changes in oxygen supply
详细描述
Cerebral protection is a major issue in the treatment of neonates and infants with complex congenital heart disease, because most common long-term morbidities of newborn heart surgery are related not to the heart, but instead to the cognitive challenges experienced by this population. Disruption of cerebral autoregulation in the postoperative period may contribute to brain injury in these patients. Blood pressure management, respirator management and red blood cell transfusion management after cardiopulmonary bypass surgery using endpoints such cerebral autoregulation monitoring might provide a method to optimize organ perfusion and improve neurologic outcome from cardiac surgery in the vulnerable postoperative period.
Primary Objectives: Feasibility of non-invasive cerebral autoregulation measurement at the PICU: Identification of the range of mean arterial blood pressure (MAP) with optimal vasoreactivity (MAPOPT), indicating intact cerebral autoregulation.
Secondary Objectives: Impact of decreased oxygen delivery, increased cerebral oxygen extraction, decreased cardiac output, arterial hypotension, severe hypoxemia and/or severe anemia on cerebral autoregulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •term (37-42 weeks gestation) newborns
- •pre- or postnatally diagnosed critical congenital heard disease (CHD)
- •admitted to the pediatric cardiac intensive care unit at the Children's Hospital of Tübingen
排除标准
- •birth weight <2 kg
- •history of neonatal depression (5-min APGAR<5, cord blood pH<7.0, sepsis, or birth asphyxia)
- •perinatal seizures
- •evidence of end-organ injury
- •preoperative cardiac arrest
- •significant preoperative intracerebral hemorrhage such as grade 3 or 4 intraventricular hemorrhage.
结局指标
主要结局
Range of mean arterial blood pressure
时间窗: 4within 8 hours after cardiac surgery at the PICU
Measurement of the range of mean arterial blood pressure (MAP) with optimal vasoreactivity (MAPOPT)
次要结局
- Influence of changed fractional cerebral oxygen extraction (cFTOE) on cerebral autoregulation(within 8 hours after cardiac surgery at the PICU)
- Influence of changed arterial oxygen saturation on cerebral autoregulation(within 8 hours after cardiac surgery at the PICU)
- Neurological outcome measure(at age of 2 years)
- Detection of severe brain injury(before surgery, 12 hours, 48 hours, 72 hours post surgery and before discharge)
- Influence of changed arterial blood pressure on cerebral autoregulation(within 8 hours after cardiac surgery at the PICU)
- Influence of changed blood hemoglobin concentration on cerebral autoregulation(within 8 hours after cardiac surgery at the PICU)