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临床试验/NCT05742737
NCT05742737已完成不适用

Frailty Index as An Indicator Associated With Postoperative Adverse Outcomes In The Older Population

Weidong Mi1 个研究点 分布在 1 个国家目标入组 12,000 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12,000
试验地点
1
主要终点
1-month all-cause mortality

研究概览

简要总结

This study is a observational study in China, which aims to explore the predictive effect of preoperative frailty defined by the modified frailty index in predicting postoperative survival and complications in elderly patients.

The objectives of the study include:

  1. To demonstrate that the frailty scale can predict short- and long-term survival after surgery in elderly surgical patients; 2 Demonstrated that frailty as defined by this scale is associated with postoperative complications in older patients

详细描述

Traditionally, frailty has been described as the form of chronological age. Evaluating the patient's risks based solely on age is difficult, several other factors contribute to physiologic aging and determine functional reserve and response to the risk of postoperative complications. To meet the clinical demand for simpler frailty measurement tools, a simplified 5-index modified frailty index (mFI-5) has been proposed and validated in many literatures. However, there is a lack of evidence on the link between preoperative weakness and poor prognosis in elderly patients undergoing non cardiac surgery.

Therefore, the purpose of this study is to verify the prognostic value of mFI-5 for short-term and long-term adverse outcomes such as postoperative delirium, anxiety, depression, acute pain, and mortality in elderly non-cardiac surgery patients. Our hypothesis is that frailty may be highly correlated with postoperative mortality and adverse outcomes in elderly patients undergoing non-cardiac surgery, and that mFI-5 may be an effective risk prediction tool for decision-making and surgical planning.

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

  • (1) participants ≥ 65 years of age;

排除标准

  • lacked any covariate indicator or missing data for any confounder (such as demographic information, intraoperative surgery or anesthesia information);
  • ASA physical status Ⅴ;
  • Anesthesia other than general intravenous anesthesia or intravenous inhalation anesthesia;
  • Surgery time ≤ 60 min.

结局指标

主要结局

1-month all-cause mortality

时间窗: postoperative 1-month

1-month postoperative mortality in elderly patients over 65 years of age

12-month all-cause mortality

时间窗: postoperative 12-month

12-month postoperative mortality in elderly patients over 65 years of age

6-month all-cause mortality

时间窗: postoperative 6-month

6-month postoperative mortality in elderly patients over 65 years of age

次要结局

  • Readmission rates(postoperative 30-day)
  • Admission to ICU(From the moment of living operation room to the moment of discharge from hospital,up to 7 day)
  • major complications(From the moment of living operation room to the moment of discharge from hospital,up to 7 day)

研究者

发起方
Weidong Mi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Weidong Mi

Director of anesthesiology department

Chinese PLA General Hospital

研究点 (1)

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