Predicting Cerebrovascular Adverse Events Post Cardiac Surgery With Cardiopulmonary Bypass by Means of Cerebral AutoreguLation Indices
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Cerebral Oxymetry index (CoX)
研究概览
简要总结
The aims of this study are: i) to assess cerebral autoregulation and autonomic control within the different phases of cardiac surgery with cardiopulmonary bypass; ii) to compare cerebral autoregulation measures derived via cerebral blood flow velocity estimated by transcranial Doppler device with simpler measurements derived from near infrared spectroscopy; iii) to develop a predictive model of postoperative cerebrovascular outcome (overt or silent stroke) based on the extracted indices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age older than 18 years
- •spontaneous sinus rhythm
- •no pregnancy
- •signed informed consent
排除标准
- •age lower than 18 years
- •absence of sinus rhythm
- •autonomic disorders
- •concomitant carotid intervention
- •reintervention
- •contraindication to MRI
- •pregnancy
- •impossibility of informed consent
研究组 & 干预措施
Cardiac surgery with cardiopulmonary bypass patients
Patients will be enrolled before cardiac surgery with cardiopulmonary bypass (CPB) and monitored until after the surgery. Patients enrolled will undergo diffusion weighted magnetic resonance imaging and will be administered with cognitive tests one day before surgery and within one week after surgery. Cerebral blood flow velocity as derived from transcranial Doppler recordings will be acquired from the middle cerebral artery synchronously with arterial pressure, invasively derived from the radial artery, and with the electrocardiogram as derived from patient's monitor. Signals will be acquired before anesthesia induction (BASAL), after anesthesia induction and intubation of the chest (ANESTH) and during CPB (CPB). Each acquisition will last at least 5 minutes and will be prolonged to the maximum possible length in keeping with clinical scheduling. Partial pressure of carbon dioxide and other clinical parameters will be acquired too during the intervention.
干预措施: Cerebral autoregulation monitoring (Diagnostic Test)
结局指标
主要结局
Cerebral Oxymetry index (CoX)
时间窗: 36 months
CoX is an index describing the state of cerebral autoregulation derived from NIRS and mean arterial pressure. It ranges between 0 and 1. CoX = 1 means perfect coupling. Cox=0 means uncoupling. It will be computed for all participants in BASAL, ANESTH, CPBasurements derived from near infrared spectroscopy
Autoregulation index (ARI)
时间窗: 36 months
ARI is an index describing the state of cerebral autoregulation from mean cerebral blood velocity and mean arterial pressure. It ranges between 1 and 9. ARI\>4 means working autoregulation. ARI\<4 means impaired autoregulation. It will be computed for all participants in BASAL, ANESTH, CPB.
number of patients developing cerebrovascular adverse events
时间窗: 36 months
The number of patients developing cerebrovascular adverse events will be assessed by the presence of positive lesions as detected by DW-MRI.
次要结局
- Baroreflex sensitivity(36 months)
研究者
Vlasta Bari
Principal Investigator
IRCCS Policlinico S. Donato