Effects of Remote Ischemic Preconditioning(RIPC) on the Prevention of Postoperative Delirium in Patients Undergoing Cardiac Surgery: A Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 216
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
Postoperative delirium (POD) is one of the most frequent neurological complications in elderly patients and is closely associated with longer ICU stay and hospitalization, deterioration of long-term neurocognitive function, and increased mortality. The incidence of POD is significantly higher in elderly patients undergoing cardiac surgery than in other populations. Therefore, the prevention of POD is an important clinical problem to be solved urgently. In this study, we intend to observe the effect of RIPC on the prevention and treatment of POD in patients undergoing cardiac surgery through a prospective randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing elective cardiac surgery;
- •age ≥ 18 yr;
- •American Society of Anesthesiologists (ASA) class ≥II class;
- •New York Heart Association (NYHA) ≥II class.
排除标准
- •emergency surgery;
- •a history of cardiovascular surgery;
- •peripheral vascular disease affecting the upper limbs;
- •acute myocardial infarction (MI) up to 14 days before surgery;
- •a history of severe injuries and operations within 3 months before cardiac surgery;
- •a history of cancer and chronic autoimmune diseases.
结局指标
主要结局
Incidence of postoperative delirium
时间窗: 7 days postoperatively or before discharge, whichever came first
Patients were assessed for postoperative delirium by the Confusion Assessment Method (CAM) from the time they were transferred to the ICU at the end of surgery until 7 days postoperatively or before discharge, whichever came first
次要结局
未报告次要终点