Intraoperative Venous Congestion And Delirium After Cardiac Surgery: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Postoperative delirium after surgery
研究概览
简要总结
Postoperative delirium (POD) is an acute brain dysfunction characterized by inattention, impaired consciousness, and cognitive and orientation disturbances, and is a common complication after cardiac surgery. The high incidence of up to 52% of POD in cardiac surgery patients lead to a range of adverse clinical outcomes.The brain tissue is enclosed in a rigid anatomical structure; when there is an obstruction to venous return from the brain, intracranial pressure can increase, and blood supply to the brain tissue can decrease, leading to central nervous system dysfunction.
Systemic venous congestion can occur when there is right heart dysfunction or excessive volume load. When right heart failure and/or volume overload occurs, changes in right atrial pressure are transmitted to the venous system of organs throughout the body, with dilatation of the inferior vena cava (IVC), obstruction of blood return from the hepatic, portal, and renal veins, and abnormal venous flow signals and altered ultrasound Doppler flow patterns.
The primary objective of this prospective cohort study is to explore if intraoperative systemic venous congestion is associated with POD after cardiac surgery. This study will also investigate the relationship between intraoperative systemic venous congestion and postoperative complications, and the relationship between each separate venous congestion and POD after 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 to undergo elective cardiac surgery via a midline thoracic incision;
- •A preoperative MMSE score>23, without consciousness or language barriers, capable of cooperating with neurological examinations, cognitive function tests, and other assessments of neurological function.
排除标准
- •Contraindications for TEE;
- •Emergency cardiac surgery;
- •Major vascular surgery;
- •Redo cardiac surgery;
- •Severe infection requiring continuous antibiotic therapy;
- •Severe preoperative heart failure with left ventricular ejection fraction < 30%;
- •A critical preoperative state (mechanical circulatory support, extracorporeal membrane oxygenation, current renal replacement therapy, mechanical ventilation, or cardiac arrest necessitating resuscitation);
- •Multi-organ dysfunction;
- •Known conditions that may interfere with the assessment or interpretation of hepatic vein, portal vein blood flow (such as liver cirrhosis or portal vein thrombosis) or the renal vein blood flow (such as urinary tract obstruction);
- •Planned cardiac transplantation or ventricular assist device implantation;
- •Insufficient ultrasonographic imaging;
- •Restarting CPB after first CPB cessation during surgery;
- •Requirement for cardiac assist devices (ECMO, IABP, or ventricular assist device) after CPB intraoperatively;
- •Neurological or psychiatric diagnoses that may affect cognitive performance or cognitive testing;
- •Documented delirium before surgery.
结局指标
主要结局
Postoperative delirium after surgery
时间窗: 7 days after surgery
Postoperative delirium (POD) is assessed daily using Confusion Assessment Method for Intensive Care Unit (CAM-ICU) or CAM. POD is assessed by formally trained anesthesiologists twice daily from postoperative day 1 to day 7, with assessments conducted in the morning (08:00-10:00) and the afternoon (18:00-20:00). If a positive result is obtained at any time within the first 7 postoperative days, assessments will stop and the case will be recorded as POD.
次要结局
未报告次要终点
研究者
Zhuan Zhang
MD, the Deputy Director of Anesthesiology, the Affiliated Hospital of Yangzhou University, Yangzhou University
Yangzhou University