跳至主要内容
临床试验/NCT07323940
NCT07323940招募中不适用

Correlation Between Multiscale Entropy Analysis of Electroencephalograms and Postoperative Delirium Incidence.

Xin Chen1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年12月12日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Incidence of postoperative delirium

研究概览

简要总结

This clinical study aims to investigate whether multiscale entropy analysis of electroencephalogram data can distinguish between ordinary elderly surgical patients and elderly patients with postoperative delirium.This study may help identify postoperative delirium in surgical patients at an early stage.

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

入选标准

  • Patients undergoing general anaesthesia with single-lumen endotracheal tube placement;
  • Age ≥65 years, gender unrestricted, body mass index (BMI) 18-28 kg/m²;
  • Normal mouth opening and head/neck mobility;
  • Pre-anaesthesia American Society of Anaesthesiologists (ASA) physical status classification of I or II and Mallampati airway classification of I or II.

排除标准

  • Individuals with psychiatric disorders, literacy issues, or communication difficulties who are unable to cooperate with POD screening;
  • Patients with severe lesions in vital organs, such as the heart, lungs, brain, liver or kidneys.
  • Those undergoing cardiac or neurosurgical procedures during this admission;
  • A history of alcohol abuse or recent use of sedatives or opioids;
  • haemoglobin <100 g/L;
  • Participation in any clinical research studies within the past 3 months.

研究组 & 干预措施

Elderly surgical patients undergoing general anaesthesia.

干预措施: Collect preoperative and intraoperative electroencephalogram data (Device)

结局指标

主要结局

Incidence of postoperative delirium

时间窗: Within seven days after surgery(Day 0-7)

Using the 3D-CAM scale to assess postoperative delirium in surgical patients.

次要结局

未报告次要终点

研究者

发起方
Xin Chen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xin Chen

Associate Researcher,the Second Affiliated Hospital of Hainan Medical University

Hainan Medical College

研究点 (1)

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