The Effect and Mechanism of Computerized Cognition Training on the Incidence of Postoperative Cognitive Dysfunction After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 174
- 主要终点
- Incidence of postoperative 7-day cognitive dysfunction
研究概览
简要总结
Whether enough time and high-quality cognitive training will reduce the incidence of postoperative cognitive dysfunction after cardiac surgery.
详细描述
Firstly, after patients are admitted, the researchers will visit every patient, introduce the study protocol, the risks and rights of the subjects to them in detail, and obtain their signed informed consent. Then, researches will collect the baseline data of the patients and complete the baseline status data measurement, including cognitive function, sleep quality, anxiety and depression scores, multi-channel EEG recorder monitoring and functional magnetic resonance examination.
According to the results of randomization, the intervention will be carried out according to the study protocol.
The day before the operation, EEG cortical network connection status, cognitive function, sleep quality, anxiety and depression scores will be measured after the intervention to understand the effect of preoperative intervention on brain function.
On the day of operation, anesthesia and operation will be performed according to clinical routine. And the multi-channel EEG will be detected after induction of anesthesia and during the period of sedation and recovery.When the patient meets the appropriate conditions, cognitive function training will be started as soon as possible.
Researches will evaluate the patients' sleep quality and the incidence of delirium in the first six days after the operation. They will also evaluate cognitive function, sleep quality, anxiety and depression scores, and conduct postoperative delirium evaluation, multi-channel EEG recorder monitoring, functional magnetic resonance examination on the seventh day after operation.The cognitive function, sleep quality, anxiety and depression scores will be measured 30 days after operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agree to participate in this study voluntarily;
- •Age ≥ 60 years old；
- •Patients who intend to accept elective coronary artery bypass grafting or valve replacement；
- •The preoperative hospital stay is expected to be 5 days or more.
排除标准
- •Definite diagnosis of senile dementia and Montreal Cognitive Assessment(MoCA) score ≤ 18;
- •Patients with severe visual or hearing impairment who cannot complete the cognitive function assessment;
- •Patients with limb movement disorder who cannot complete the cognitive function assessment;
- •Patients with claustrophobia who cannot complete functional magnetic resonance imaging(fMRI) examination;
- •The expected survival time is less than 1 month;
- •Patients within 3 months or participating in other clinical trials.
结局指标
主要结局
Incidence of postoperative 7-day cognitive dysfunction
时间窗: The 7th day after operation
次要结局
- Postoperative 7-day changes of cognitive scores(The 7th day after operation)
- Postoperative 30-day main complications and mortality(The 30th day after operation)
- Postoperative 7-day changes of sleep quality(The 7th day after operation)
- Incidence of postoperative delirium within 7 days(Within 7 days after operation)
- Incidence of postoperative 30-day cognitive dysfunction(The 30th day after operation)
- Postoperative 7-day changes of cortical network connectivity function(The 7th day after operation)
研究者
Mu Dong Liang
Deputy chief physician
Peking University First Hospital