跳至主要内容
临床试验/NCT07314762
NCT07314762招募中不适用

Elderly Patients Undergoing Surgery During Perioperative Period: a Prospective Cohort Study

Second Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2023年12月30日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,200
试验地点
1
主要终点
Incidence of postoperative delirium (POD) within 7 days after surgery

研究概览

简要总结

The elderly patients have poorer overall conditions and have lower tolerance to trauma, anesthesia, and surgery. Therefore, the incidence of postoperative complications is relatively higher. In non-cardiac surgeries, approximately 20% of elderly patients experience postoperative complications, and the incidence of postoperative delirium (POD) is 23.8%. This may lead to prolonged hospital stays, increased hospital costs, and affect prognosis and even mortality. The investigators plan to conduct a prospective cohort study by systematically collecting biological samples and clinical information of elderly patients during the perioperative period to explore the possible risk factors and pathogenesis of postoperative delirium and postoperative complications in elderly surgical patients, and to construct a risk prediction model for postoperative complications.

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

  • 1) Surgical patients aged 65 or above or non-surgical subjects aged 65 or above. 2) Agree to participate in this study and sign the informed consent form.

排除标准

  • 1)Refused to participate in the study.

结局指标

主要结局

Incidence of postoperative delirium (POD) within 7 days after surgery

时间窗: Preoperative, postoperative day 1, 3, 5 and 7

POD is diagnosed daily using the Three-Minute Diagnostic Confusion Assessment Method (3D-CAM).

次要结局

  • Acute pain(Preoperative, postoperative day 1 and 3)
  • The types of postoperative delirium(Preoperative, postoperative day 1, 3, 5 and 7)
  • The severity of postoperative delirium(Preoperative, postoperative day 1, 3, 5 and 7)
  • The duration of postoperative delirium(Preoperative, postoperative day 1, 3, 5 and 7)
  • Hospital Anxiety and Depression Scale (HADS) score(Preoperative, postoperative day 1, 5, 30, and at 1 year.)
  • Postoperative neurocognitive dysfunction(Preoperative, postoperative day 1, 5, 30, and at 1 year.)
  • Sleep quality(Preoperative, postoperative day 5, 30, and at 1 year.)
  • Activity of Daily Living(Preoperative, postoperative day 1, 5, 30, and at 1 year.)
  • Mortality(During hospitalization, and postoperative day 30 and at 1 year.)
  • Quality of Life Score(Preoperative, postoperative day 5, 30, and at 1 year.)
  • The FRAIL Scale(Preoperative, postoperative day 5, 30, and at 1 year.)
  • Length of hospitalization(till the day of discharge from hospital, an average of 7 days)
  • Days at home up to 30 days after surgery (DAH30)(up to 30 days after surgery)
  • Economic indicators(during the entire trial, an average of 1 year.)

研究者

发起方
Second Affiliated Hospital of Wenzhou Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ting Li

Principal Investigator

Second Affiliated Hospital of Wenzhou Medical University

研究点 (1)

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