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临床试验/NCT05246254
NCT05246254招募中不适用

The Association of Preoperative Frailty Index and Incidence of Postoperative Delirium in Elderly Patients With Hip Fracture: a Prospective Cohort Study

Beijing Tsinghua Chang Gung Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Incidence of postoperative delirium(POD) in elderly patients with hip fracture

研究概览

简要总结

Several studies have shown that frailty can be used as a marker for risk of adverse outcomes in elderly patients such as falls, disability, hospitalization, mortality, and can be used to predict patient clinical outcomes. The purpose of this study is to determine whether preoperative frailty can be used as a diagnostic and predictive factor for postoperative delirium in elderly patients with hip fracture.

详细描述

Frailty index (FI) is a reliable method to determine the assessment of frailty in elderly patients. Multiple prospective cohort studies have shown that frailty can be used as a marker for risk of adverse outcomes in older adults such as falls, disability, hospitalization, and mortality, and can be used to predict patient clinical outcomes. Whether frailty could be used as a diagnostic and predictive factor for delirium is urgently needed in a large population.

Therefore, this project intends to conduct a prospective cohort study. Patients will be divided into three groups according to frailty index (FI) before surgery, and delirium status will be evaluated by using scales after surgery, so as to explore the diagnostic and predictive value of frailty on POD. Once confirmed, the results of this study will be helpful for the early identification, screening, diagnosis and evaluation of treatment effect of POD. It is of great scientific significance and social benefit to reduce the incidence of POD, improve the prognosis of vulnerable patients and reduce the burden of disease.

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

  • The subjects were patients with hip fracture;
  • Older than 65 years;
  • Patients signed informed consent;
  • American Society of Anesthesiologist (ASA) Rated I- III;
  • The surgery was performed by the same anesthesia and surgical team.

排除标准

  • Patients cannot sign the consent form or refuse to participate;
  • A history of cognitive impairment;
  • Unable to complete the cognitive function test;
  • Mental disorder during initial assessment;
  • Patients suffering from mental illness or substance use disorder;
  • Incomplete or lost data during follow-up.

结局指标

主要结局

Incidence of postoperative delirium(POD) in elderly patients with hip fracture

时间窗: Postoperative 7 days

The percentage of the study population who developed delirium within seven days of surgery,postoperative delirium(POD) is defined according to the CAM criterion

次要结局

  • Duration of delirium(Postoperative 7 days)
  • Length of hospital stay (HLOS)(Postoperative 30 days)
  • Length of ICU stay(Postoperative 30 days)
  • Hospital cost(Postoperative 30 days)
  • Death before and 30 days after discharge(30 days after discharge)
  • Delirium drug use(Postoperative 7 days)
  • Dindo-Clavien Classification{References:Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004; 240(2):205-213.}(Postoperative 30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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