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临床试验/NCT03260218
NCT03260218Unknown不适用

Protocol for a Single-Centre Prospective Observational Study of Postoperative Delirium Following Total Joint Arthroplasties Among South East Asians

Singapore General Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2017年7月3日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
Post operative delirium incidence

研究概览

简要总结

The incidence of post-operative delirium in the South-east Asian population is not known. Through a prospective, single centre, observational study, the investigators aim to characterize the incidence and risk factors of delirium in older adults undergoing elective total joint arthroplasties (TJA). The study will recruit eligible patients (65 - 90 years old undergoing elective TJA), with a targeted sample size of 500. Patients will be screened for dementia and Confusion Assessment Method (CAM) scores obtained pre and post operatively. Other data such as preoperative Charlson comorbidity index (CCI), post op complications using Post operative Morbidity Survey (POMS), pain scores, readmission rates and length of hospital stay (LOS), functional and health-related quality-of-life (HRQoL) will also be collected and analysed.

详细描述

BACKGROUND

Modern studies have evaluated the risk factors and incidence of postoperative delirium in post-TJA patients. In current literature, incidence ranges from 0-10%. However, the epidemiology of these studies mainly focused on non-Asian populations. The investigators hope to determine both the incidence and risk factors of postoperative delirium in patients undergoing TJA with a focus on the Asian population. This is especially relevant in today's ageing Asian population.

AIMS

To characterize the incidence and risk factors of delirium in older adults undergoing elective total joint replacement surgery.

HYPOTHESIS

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients undergoing elective total knee or total hip arthroplasty

排除标准

  • •Patients who are deemed to lack mental capacity to give consent.

结局指标

主要结局

Post operative delirium incidence

时间窗: Up to 30 days

Measured using confusion assessment method (CAM) tool

次要结局

  • incidence of post operative nausea and vomiting (PONV)(post op day 1)
  • Post operative complications(Up to 30 days post operatively)
  • functional and health-related quality-of-life (HRQoL)(6 months , 12 months)
  • Days Alive and Out of Hospital (DAOH)(1 month, 6 months, 12 months)
  • Length of hospital stay(up to 12 months)
  • Hospital readmission rate(30 days post operative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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