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临床试验/NCT05320965
NCT05320965Unknown不适用

Prospective Validation of the Model Predicting Postoperative Delirium Occurrence With Machine Learning-based Analysis of Intraoperative Biological Signals During Anesthesia in Cardiac Surgery

Yonsei University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年3月17日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Postoperative delirium

研究概览

简要总结

Postoperative delirium (POD) not only increases the length of hospitalization and intensive care unit stay and medical costs, but is also closely associated with negative prognosis, including postoperative mortality, increased morbidity, long-term cognitive decline after surgery, and impaired quality of life and independence. The preoperative risk assessment and early detection of POD are very important in the proper management of POD. This is because drug treatment that can prevent or treat POD is limited, and for its prevention and management, a multidisciplinary approach and resource management covering almost all aspects of patient management are required. Therefore, if there is a model that can predict the occurrence of POD, it can be of great help in managing delirium after cardiac surgery through more accurate risk assessment and early detection. In previous studies, aging and cognitive decline before surgery are known as major risk factors for POD, but identification of risk factors before surgery alone is insufficient to predict the occurrence of POD. Cardiac surgery is highly likely to cause pathophysiological changes that can cause POD, because it is associated with hemodynamic instability, cardiopulmonary use, changes in body temperature, and systemic inflammatory response. These pathophysiological changes can be reflected in the data (biosignals) obtained through various monitoring devices during anesthesia. Most of the events that occur during anesthesia are considered to be correctable risk factors of POD, unlike preoperative risk factors, and there is a potential to reduce the occurrence of POD by actively correcting them. Therefore, it is necessary to analyze the effect of these intraoperative biosignals on POD. In the delirium prediction model development process, rather than simply dividing the already collected data and using it in the model performance validation process, it is better to conduct model performance validation based on patient data prospectively collected to prevent overfitting and achieve higher predictive performance. Therefore, this study aims to collect prospective data to evaluate the performance of the delirium prediction model after cardiac surgery built using machine learning techniques based on the already collected data including biosignals during anesthesia. After reviewing the medical records from the day of surgery to the period of stay in the ICU, if the Intensive Care Delirium Screening Checklist (ICDSC) score is 6 or higher or there is a record of consultation with delirium, it is recorded as POD. After structuring the database through purification, standardization, outlier detection, and sampling of biosignal data generated during surgery, various variables obtained from medical records are collected to construct an evaluation dataset. Using this dataset, the performance of the delirium prediction model built by applying the machine learning algorithm is evaluated through Receiver Operating Characteristic curve analysis.

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
19 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults between 19 and 100 years of age
  • Patients scheduled for cardiac or aortic surgery

排除标准

  • Patients with a history of major neurocognitive disorder, major depressive disorder, and alcohol or drug dependence before surgery
  • Patients who have already lost consciousness before surgery

结局指标

主要结局

Postoperative delirium

时间窗: up to 7 days post-surgery

The Intensive Care Delirium Screening Checklist (ICDSC) score is 6 or higher

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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