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临床试验/NCT06318364
NCT06318364招募中不适用

Analysis of the Incidence and Influencing Factors of Postoperative Delirium in the Post-anesthesia Care Unit: A Multicenter, Observational, Matched Case-control Study

Qin Zhang2 个研究点 分布在 1 个国家目标入组 3,320 人开始时间: 2024年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
3,320
试验地点
2
主要终点
Postoperative delirium

研究概览

简要总结

This study aims to investigate the incidence of postoperative delirium (POD) in the PACU and analyze its influencing factors, in order to provide theoretical basis for early screening and intervention for high-risk POD population. Blood samples of some study subjects will be collected and analyzed using molecular detection methods to provide a basis and insights into the pathophysiological mechanisms of POD.

详细描述

Study design type: Multi-center, observational, case-control study based on propensity score matching. The leading unit is Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, and the participating unit is The First Hospital of Harbin Medical University.

Record general clinical information, surgical-anesthesia-related information, recovery indicators, pain status, adverse events in PACU, and occurrences of postoperative delirium of all study subjects meeting the inclusion criteria of this study. Based on the occurrence of postoperative delirium, the subjects will be divided into delirium group and non-delirium group for univariate analysis. Univariate factors with statistical significance will be included in a multiple logistic regression analysis to further identify risk factors for postoperative delirium. Some selected factors can undergo ROC curve analysis to calculate the optimal cutoff value. Due to the limited number of subjects experiencing postoperative delirium, propensity score matching will be used to improve the statistical efficiency for analysis of risk factors for postoperative delirium. Furthermore, for patients with postoperative delirium, a small amount of blood samples will be collected by the researchers for analysis of inflammatory factors and other components.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients voluntarily participating in this study
  • Age ≥18 years old
  • ASA classification I-IV
  • Complete clinical data

排除标准

  • ASA classification V and above
  • History of severe central nervous system diseases, psychiatric disorders, cognitive impairment, intellectual disability, or Mini-Mental State Examination (MMSE) score ≤23
  • Patients with communication barriers
  • Patients with missing clinical data
  • Patients with severe complications during PACU observation requiring reintubation, reoperation, or transfer to the intensive care unit for further treatment

结局指标

主要结局

Postoperative delirium

时间窗: 1 Hour

Mini-Mental State Examination, MMSE

次要结局

未报告次要终点

研究者

发起方
Qin Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Qin Zhang

Professor

Tongji Hospital

研究点 (2)

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