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临床试验/NCT04527341
NCT04527341Unknown不适用

Study on Visual Assessment System and Stratified Management Program for Postoperative Delirium After Cardiac Surgery

Shanghai Zhongshan Hospital0 个研究点目标入组 500 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
主要终点
Incidence of postoperative delirium

研究概览

简要总结

Postoperative Delirium (POD) is a common complication in patients after cardiac surgery, which is associated with short-term prognosis and long-term quality of life. Due to the lack of specific treatment, prevention is the most effective strategy to reduce delirium. Risk assessment greatly contributes to guide prevention by stratifying the risk of the POD. However, the high-quality risk assessment tools are still sparse, and the combination of risk assessment and stratified prevention has not been applied to the management of delirium after cardiac surgery. In the previous work, we found the predictive value of preoperative cardiac function on POD, and found a critical value. On the basis of previous research, this project will learn from previous studies on risk factors of POD, and deeply explore potential predictors. Furthermore, we will develop and validate POD risk prediction model, and then develop it into a visual evaluation system. In addition, based on the theory of risk management and risk assessment tools, using the concepts and methods of evidence-based medicine, the risk assessment system and stratified management program of POD will be formed and evaluated by expert discussion meetings. It is expected that the risk assessment system and stratified management program constructed by this project could simply and quickly screen high-risk patients and carry out timely intervention, so as to reduce the incidence of POD, improve patients' prognosis and the quality of life after cardiac surgery.

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

入选标准

  • Aged above 18
  • Patients after cardiac surgery
  • Admitted to ICU after surgery

排除标准

  • Preoperative delirium or dementia patients
  • Unable to fully participate in delirium testing, including blind, deaf, illiterate or inability to understand Chinese
  • Undergoing surgery procedures do not require admission to SICU
  • Transfer to ICU from wards after surgery

结局指标

主要结局

Incidence of postoperative delirium

时间窗: up to 5 days postoperatively

Investigators defined patients have delirium if they had at least one positive screening during ICU stay.

次要结局

  • Severity of postoperative delirium(up to 5 days postoperatively)
  • duration of postoperative delirium(up to 5 days postoperatively)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

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Postoperative Delirium in Cardiac Surgery ICU | 临床试验