Feasibility Study of the Use of Biomarkers to Detect Perioperative Brain Injury: the Association Between Serum Neurofilament Light Chains, Tau Proteins, Continuous Intra-operative Electroencephalography, and the Development of Post Operative Cognitive Dysfunction After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Feasibility to conduct the study
研究概览
简要总结
Loss of cognitive function after major surgery is a significant risk in older people. It can occur acutely in the days after surgery as delirium or in months to years later as a persistent reduction in brain function termed neurocognitive decline. Together these conditions are called post operative cognitive dysfunction (POCD). They can be acutely distressing for patients and are associated with other problems after surgery.
The causes of post operative cognitive dysfunction are poorly understood. Studies have been limited by a lack of biomarkers to predict which patients are at high risk of developing POCD. Research suggests silent strokes occurring during surgery and different sensitivities to anaesthetic medicines are associated with POCD.
The project consists of a feasibility study to investigate markers that might predict people over 65 years old getting POCD. The first biomarker is a non-invasive monitor of anaesthetics effects on brain function called electroencephalography (EEG): The investigators will identify which EEG patterns predict delirium within five days surgery. The second set of biomarkers are two blood tests of proteins that increase after strokes: these are neurofilament light chains and tau proteins. The investigators will establish if these can be used to predict having POCD up to one year after surgery and long term cognitive impairment up to 5 years after surgery.
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
- 否
入选标准
- •Greater than or equal to 65 years of age
- •Having elective non-cardiac surgery under general anaesthesia
- •Anticipated to have at least 48 hours of inpatient admission
- •Able & willing to give informed consent
排除标准
- •Unable to participate in neurocognitive assessments
- •Presence of delirium prior to surgery
- •Contraindication to use of EEG electrodes (e.g. known allergy to a component of the electrodes)
- •Known history of severe traumatic brain injury
- •Learning disability specifically with a known structural brain lesion
- •Known history of dementia
- •Participants undergoing operations on the carotid artery
结局指标
主要结局
Feasibility to conduct the study
时间窗: 1 year after surgery
The total number of participants who are successfully recruited, receive the study procedures and complete both 90 day and 1 year follow up after surgery.
次要结局
- Postoperative delirium incidence and severity(Up to 5 days after surgery)
- Long term cognitive impairment(Up to 5 years after surgery)
- Days alive and at home up to 90 days after surgery(90 days after surgery)
- Postoperative neurocognitive dysfunction and severity(Up to 1 year after surgery)
- Change in neurofilament light chains and tau proteins levels pre- to post operatively(Up to 2 days after surgery)