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临床试验/NCT05189678
NCT05189678Unknown不适用

Correlation Between Modified Weakness Index and Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery: a Single-center Prospective Observational Cohort Study

Qianfoshan Hospital1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2021年11月22日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1
试验地点
1
主要终点
Postoperative Delirium

研究概览

简要总结

  1. To study whether there is a correlation between weakness and postoperative delusions in elderly non-cardiac surgery patients
  2. Can the improved debilitating index predict the delusion after non-cardiac surgery
  3. Which of the debilitating index are independent risk factors associated with postoperative delusions

详细描述

Early identification of frailty patients is of great clinical significance for preoperative decision making and prognosis assessment. To date, the incidence of postoperative delirium in elderly patients undergoing noncardiac surgery has not been assessed. This study aimed to investigate the relationship between preoperative frailty assessment and the incidence of postoperative delirium after noncardiac surgery.

  1. To study whether there is a correlation between weakness and postoperative delusions in elderly non-cardiac surgery patients
  2. Can the improved debilitating index predict the delusion after non-cardiac surgery
  3. Which of the debilitating index are independent risk factors associated with postoperative delusions

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
70 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 70 years old;
  • ASA: Grade Ⅰ~Ⅳ;
  • Signed informed consent;
  • Scheduled non-cardiac surgery.

排除标准

  • Refuse to participate;
  • Expected length of stay <3 days;
  • The same patient can only be included once, regardless of whether the reason for the second operation is related to the first cause;
  • Emergency surgery patients;
  • Inability to communicate due to illiteracy, language impairment, severe hearing or visual impairment;
  • Central nervous system diseases, including various types of dementia and depression
  • Severe renal insufficiency (requiring dialysis treatment);
  • Severe liver dysfunction (Child-Pugh score ≥10);
  • Patients who have participated in other relevant clinical studies within 3 months MMSE examination has confirmed the existence of cognitive dysfunction: illiteracy ≤17 points, primary school degree ≤20 points, middle school degree (including technical secondary school) ≤22 points, university degree (including junior college) ≤23 points

结局指标

主要结局

Postoperative Delirium

时间窗: Twice a day from day 1 to 3 after surgery (8:00-10:00 am and 18:00-20:00 PM).

Incidence of postoperative delirium after noncardiac surgery.Postoperative delirium usually occurs between 24 hours and 72 hours after surgery, and this study will conduct follow-up assessments at six postoperative time points (once in the morning and afternoon on days 1 to 3 after surgery, 8:00 a.m.-10:00 a.m., 18:00-20:00 pm), as long as there was one time point to assess postoperative delirium, the patient was judged to have developed postoperative delirium.

次要结局

  • complications(Within 30 days after surgery)
  • Incidence of 30-day readmission to hospital(Within 30 days after surgery)

研究者

发起方
Qianfoshan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lili Cao

Professor

Qianfoshan Hospital

研究点 (1)

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