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临床试验/NCT04056871
NCT04056871已完成不适用

Comparing the Association of Different Frailty Scores to the Incidence of Post-operative Delirium and Cognitive Dysfunction

University of Malaya1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2019年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
1
主要终点
Change in cognitive function using Telephone-Montreal Cognitive Assessment (T-MOCA)

研究概览

简要总结

Patients who are frail will have higher rate for post-operative morbidities, mortality, prolonged hospital stays, loss of independence, increase in institutionalization, post-operative cognitive dysfunction (POCD) and delirium (POD).

So, it is crucial to find a suitable frailty assessment tool that can be incorporated into a guideline and reference for our local setting in geriatric peri-operative management. In the mean time, create awareness regarding the frailty elderly population with POD, POCD and other associated poor outcomes among our clinicians.

详细描述

Increasing life expectancy has led to increase in elderly populations, thus the elderly patients amounting for greater proportion of surgical cases. But, most of them are frail with multiple co-morbidities and are exposed to adverse outcome post-operatively. The commonest adverse outcomes is post-operative delirium (POD) in which clinicians often miss and often take lightly. If it is not treated, it will progress to post-operative cognitive dysfunction (POCD).

So, it is crucial to identify the risk factors pre-operatively to minimize the risk of POD and POCD. The frail patients are more likely to have pre-existing cognitive impairment with reduced cognitive reserve, hence, they are the most vulnerable to POCD and POD. One of the most commonly used frailty screening tools is Fried Frailty criteria which is an easily accessible tool that mainly screens and scores the patients physically. However, the investigators propose to use the Groningen Frailty scale as it can assess the patients in a more holistic approach, not only in physical, but also vision, heating, nutritional, co-morbidities, cognition, psychosocial and mobility of the patients.

Method:

Elderly patients >65 years old undergoing elective surgery under general or local anaesthesia in University Malaya Medical Centre will be recruited for this study, over a 6 months period from August 2019 to January 2020. Patients will be assessed with baseline cognitive assessment, nutritional status, psychological status, and frailty scores prior to the surgery. After the operation, patients will be assessed using 4AT and CAM for at least 5 days or until patients discharged. Cognitive functions will be assessed on post-operative 7th day, 1 month and 3 months with T-MOCA via phone.

All data will be analyzed using SPSS.

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

  • Age 65 years old and above
  • ASA 1 - 3
  • Elective surgery
  • Able to communicate well
  • Consented
  • Extubated at the end of surgery

排除标准

  • Cardiac and neurosurgery
  • On drugs affecting the central nervous system
  • Admission to ICU intubated to continue ventilation.
  • Refusal of consent
  • Severe hearing loss
  • Unable to use telephone/ mobile phone for communication

结局指标

主要结局

Change in cognitive function using Telephone-Montreal Cognitive Assessment (T-MOCA)

时间窗: Within 1 month

Cognitive function of the patients will be assessed after discharged and must achieved post-operative day 7 with T-MOCA via phone, subsequently assessed at 1 month and 3 month later.

Occurence of delirium using 4AT scores

时间窗: Within 5 days after surgery

A score of 4 or more suggests delirium but is not diagnostic: more detailed assessment of mental status may be required to reach a diagnosis. A score of 1-3 suggests cognitive impairment and more detailed cognitive testing and informant history-taking are required. A score of 0 does not definitively exclude delirium or cognitive impairment: more detailed testing may be required depending on the clinical context.

Occurence of confusion using Confusion Assessment Method (CAM) scores

时间窗: Within 5 days after surgery

Delirium is present if the following are present: Feature 1-Acute Change or/and Fluctuation (any symptom) AND Feature 2-Inattention AND EITHER Feature 3-Disorganized Thinking OR Feature 4-Altered Level of Consciousness

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Loh Pui San

Consultant Anaesthesiologist

University of Malaya

研究点 (1)

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