Accompanying Scientific Program for the Quality Contract Prevention of Postoperative Delirium in the Care of Older Patients (WB-QC-POD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of postoperative Delirium
研究概览
简要总结
In the course of a scientific accompanying program, the project pursues the goal of gaining further insight into a possible connection between various influencing factors and the development of postoperative delirium. Against this background, in addition to the primary goal of exploring delirium rates, we aim to identify associations between other secondary end goals like the internal circadian time or the heart rate variability and the occurrence of postoperative delirium. For this purpose, patients of the QC-POD (NCT04355195) sample will be studied.
详细描述
The project aims to improve the understanding of the internal circadian time (chronotype) and other sleep parameters, as well as further secondary end goals, in relation to the development of postoperative delirium. In the course of this the project would like to investigate the perioperative heart rate variability. Also, the association of perioperative peripheral cholinesterase activity with perioperative heart rate variability and the development of POD will be explored. Additionally, the investigator will analyze the correlation of intraoperative EEG signatures with perioperative heart rate variability, and explore any association of core body temperature and the development of postoperative Delirium.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 70 years
- •Male and female patients
- •Patients who have been included in QC-POD
- •Eligible patients* for inclusion: informed consent by the patient, preoperatively with verbal and written informed consent before the start of data collection
- •Incapacitated patients for inclusion: Written informed consent by a legal representative
- •surgery (elective and not elective)
排除标准
- •Moribund patients (palliative situation)
- •Insufficient knowledge of the German language
- •Cardiac arrhythmia (e.g. atrial fibrillation)
- •Presence of a pacemaker
- •Condition after heart transplantation
- •Inflammation in the area of the frontal sinus
结局指标
主要结局
Incidence of postoperative Delirium
时间窗: Up to the fifth postoperative day
Incidence of postoperative delirium in all postoperative patients in normal ward, intensive care unit and recovery room with a validated delirium screening tool at two points in time.
次要结局
- Duration of Delirium(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Bodytime(Before surgery)
- Chronotype 1(Up to three months)
- Chronotype 2(Up to three months)
- Heart rate variability 1(The participants are followed up until the end of hospital stay, an expected average of 7 days.)
- Heart rate variability 2(The participants are followed up until the end of hospital stay, an expected average of 7 days.)
- Body core temperature(Up to the third postoperative day)
- Electroencephalography signatures(During surgery, an expected time of two hours.)
- Sleep monitoring 1(Up to the third postoperative day)
- Sleep monitoring 2(Up to the third postoperative day)
- Sleep monitoring 3(Up to the third postoperative day)
- Insomnia Severity Index(Up to three months)
研究者
Claudia Spies
Head of the Department of Anesthesiolgy and Intensive Care Medicine CC07
Charite University, Berlin, Germany