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临床试验/NCT06226480
NCT06226480已完成不适用

Development and Validation of a Prediction Model for Postoperative Delirium in Elderly Patients After Thoracic Surgery

Affiliated Hospital of Nantong University1 个研究点 分布在 1 个国家目标入组 3,967 人开始时间: 2024年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,967
试验地点
1
主要终点
Number of participants with postoperative delirium

研究概览

简要总结

Postoperative delirium (POD) is a common and severe complication in patients undergoing major surgery, especially in the elderly. POD has been proven to be associated with increased morbidity and mortality, institutionalization, and high healthcare costs. This retrospective cohort study aimed to use machine learning methods to develop clinically meaningful models to support clinical decision making.

详细描述

The primary outcome was the incidence of POD within 3 days postoperatively. The patients will be randomly split into two datasets with split ratios of 80% and 20%.

Subsequently, 80% of the patients will be used for training, and 20% of the patients will be used for testing. Multiple machine learning algorithms will be used to develop POD risk prediction models. The discrimination ability of the prediction models will be assessed by calculating the area under the receiver operating characteristic curve (AUC). The calibration of the model will be evaluated using the Hosmer-Lemeshow goodness of fit test. Decision curve analysis (DCA) will be used to evaluate the net benefits for each threshold probability. The best model will be selected by comparing the performance between the models. Then the SHapley Additive exPlanations (SHAP) will be used to explain the best one.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged ≥ 65 years
  • elective segmentectomy, lobectomy, or esophagectomy surgeries
  • general anesthesia

排除标准

  • surgery length less than 1 hour
  • preoperative cognitive dysfunction
  • admission to the intensive care unit
  • second operation within 24 hours
  • missing data for any variables

结局指标

主要结局

Number of participants with postoperative delirium

时间窗: The first three postoperative days

The following descriptive words and the derivatives were searched from the medical records: "delirium", "agitation", "hallucinations", "combative behavior", "inattention", "confusion", "mental status change", "disorientation", "drowsy". Medical records with the presence of these keywords were reviewed by an independent researcher, and medical records presented the aforementioned symptoms preoperatively were excluded. Postoperative delirium was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria.

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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