Perioperative EEG-Monitoring and Postoperative Delirium in Patients Undergoing Cardiovascular Surgery: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
Postoperative delirium is common in patients undergoing cardiovascular surgery and associated with poor outcomes. However the pathogenesis of postoperative delirium is poorly understood. Multichannel electroencephalogram is a recognized tool for identifying neurophysiologic states during anesthesia, sleep, and arousal. The aim of the current study is to evaluate the mechanisms and predictors of postoperative delirium in patients undergoing cardiovascular surgery using electroencephalogram.
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
- •age of at least 18 years
- •normal cognitive function at the time of enrollment evidenced by a Mini-Mental State Examination (MMSE) score of more than 24 of 30
- •Chinese Mandarin as the native language
- •providing informed consent
排除标准
- •pre-existing delirium assessed according to the Confusion Assessment Method (CAM)
- •history of neurological or psychiatric disease
- •impaired vision or auditory function which may effect the assessments
- •unwillingness to participate in the study
结局指标
主要结局
Incidence of postoperative delirium
时间窗: After surgery through to postoperative day 7
The incidence of postoperative delirium was determined according to the Confusion Assessment Method (CAM) diagnostic algorithm. The algorithm consists of four clinical criteria: (1) acute onset and fluctuating course, (2) inattention, (3) disorganized thinking, and (4) altered level of consciousness. To define a patient as having delirium, both the first and the second criteria have to be present, as well as either the third or the fourth criteria. The CAM-ICU will be used for patients who are intubated in the postoperative period.
次要结局
- Worst daily pain scores at rest(After surgery through to postoperative day 7)
- Length of hospital stay(through study completion, an average of 10 days)
- Relative power of each brain waves(During the stay of the patient in the operating room, after surgery through to postoperative day 7)
- Duration of delirium(After surgery through to postoperative day 7)
- Severity of delirium(After surgery through to postoperative day 7)
- Length of stay in the Intensive Care Unit (ICU)(through study completion, an average of 5 days)
- Worst daily pain scores with exertion (deep breathing and cough)(After surgery through to postoperative day 7)
研究者
Hua Zheng
Principal Investigator
Huazhong University of Science and Technology