Brain Ultrafast Ultrasound Imaging: Application in Pediatric Cardiology: Brain Ultrafast
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Cerebral blood volume variation
研究概览
简要总结
Congenital heart defects affect 1 in 100 births in France, with rising prevalence due to better care. Despite improved survival, 40% of children post-surgery face neurological impairments, and some of them show brain lesions. Causes include heart defects, genetic syndromes, and surgeries. Some heart defects and support systems increase cerebral risks. Monitoring cerebral perfusion is difficult to assess but emerging ultrafast ultrasound offers real-time, non-invasive blood flow insights.
详细描述
Congenital heart defects affect 1 in 100 live births in France. While incidence remains stable, prevalence is rising due to improved medical care, with cases expected to double by 2050. Despite increased survival, neurological comorbidities remain a major concern, with 40% of patients undergoing childhood cardiac surgery experiencing impairments and 73% presenting MRI-detectable brain lesions postoperatively. These injuries result from congenital heart defects, haemodynamic disturbances, genetic syndromes, and neonatal surgeries with extracorporeal circulation.
Some heart defects, such as systemic-to-pulmonary shunts and cyanotic heart diseases, impair cerebral perfusion, increasing the risk of hypoxia and stroke. Mechanical circulatory support systems (e.g. ECMO, cardiopulmonary bypass) also contribute to cerebral risks due to hypoperfusion and clotting complications.
Cerebral autoregulation helps maintain stable perfusion despite blood pressure variations. However, bedside cerebral perfusion monitoring remains challenging leading to reliance on indirect methods like near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD), both with limitations. Ultrafast ultrasound (UFUS) is an emerging non-invasive technique that enables real-time quantification of cerebral blood flow, offering new insights into neonatal cerebral haemodynamics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Every patient under 2 years old any sex or gender hospitalised in the congenital heart disease unit of the intensive care and anaesthesia for cardiovascular surgery, CHU de Bordeaux.
- •Open anterior fontanella
- •congenital heart disease
- •cardiac shock necessitating mechanical circulatory support.
- •Social security affiliation
- •Parental or legal guardian's non-opposition
排除标准
- •Allergy to echocardiography gel.
结局指标
主要结局
Cerebral blood volume variation
时间窗: at baseline
Depending on hemodynamic or ventilatory situation, and exposure to vasoactive or neuroactive drugs.
次要结局
- Evolution of Arterial blood pressure(at baseline)
- Evolution of central venous blood pressure(at baseline)
- Evolution of left atrial pressure(at baseline)
- Inotropic drugs dosages(at baseline)
- Evolution of SpO2(at baseline)
- Evolution of PaCO2(at baseline)
- Evolution of SaO2(at baseline)
- Evolution of SvO2(at baseline)
- Evolution of PaO2(at baseline)
- Evolution of Hemoglobinemia(at baseline)
- Vasopressive drugs dosages(at baseline)
- Sedation dosages(at baseline)
- Analgesia dosages(at baseline)