The Predictive Value of Multimodal Brain Monitoring for Perioperative Stroke in Cardiac Surgery Patients: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 369
- 主要终点
- The incidence of perioperative stroke
研究概览
简要总结
Postoperative stroke following cardiac surgery is associated with a ninefold increase in mortality risk compared to patients without stroke. Perioperative monitoring in cardiac surgery involves a range of complex and diverse techniques, presenting significant challenges for anesthetic management. Multimodal brain monitoring technology offers a novel approach to cerebral protection during the perioperative period of cardiac surgery by integrating hemodynamic parameters, autonomic nervous responses, cerebral oxygen saturation and indices, electroencephalographic activity, and cerebral blood flow velocity. Therefore, this study aims to evaluate the comprehensive early-warning efficacy of multimodal brain monitoring for perioperative stroke in cardiac surgery patients, determine the cumulative incidence of perioperative stroke-including covert stroke-and provide a new theoretical basis for optimizing cerebral protection strategies in cardiac surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective cardiac surgery
- •Presence of at least one of the following high-risk factors for stroke: a.Peripheral vascular disease (history of peripheral artery bypass grafting, amputation for ischemia, Ankle-Brachial Pressure Index < 0.9, or history of abdominal aortic aneurysm repair).b.Cerebrovascular disease (history of stroke, transient ischemic attack, or carotid stenosis >70%).c.Renal insufficiency (Glomerular Filtration Rate < 60 mL/min/1.73m²).d.Diabetes mellitus (requiring oral hypoglycemic agents and/or insulin therapy).e.Urgent coronary artery bypass grafting (inpatient requiring revascularization due to acute coronary syndrome or myocardial infarction).f.Recent smoking history (within 1 year).g.Left ventricular ejection fraction < 35%
- •Provision of signed informed consent
排除标准
- •Contraindication to magnetic resonance imaging (e.g., claustrophobia, inability to lie flat for the duration of the study, presence of a pacemaker or implantable cardioverter-defibrillator, or other metallic implants)
- •Inability to complete cognitive function assessments
- •Patients with psychiatric, legal disabilities or under legal guardianship
- •Life expectancy of less than 3 months
- •Women who are lactating or pregnant
- •Diagnosis of any type of dementia
结局指标
主要结局
The incidence of perioperative stroke
时间窗: 48 hours preoperatively and 3-7 days postoperatively
Perioperative stroke is diagnosed by MRI
次要结局
未报告次要终点
研究者
Yuming Peng
Deputy chief of Department of Anesthesiology
Beijing Tiantan Hospital