Neurological Outcome After Minimal Invasive Coronary Artery Bypass Graft: a Single-centre Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Prevalence of cerebrovascular accident
研究概览
简要总结
Primary objectives:
Assessment of the incidence of postoperative cognitive dysfunction (POCD), cerebrovascular accident (CVA), and delirium after minimal invasive coronary artery bypass grafting (Endo-CABG).
Secondary objectives:
- Quality of life, three months after endo-CABG
- Patient satisfaction with endo-CABG and the tests performed
- The influence of various demographic and peri-operative variables on neurological outcome after endo-CABG
- Incidence of fear and depression, 3 months after endo-CABG
详细描述
Introduction:
Major improvements in surgical techniques, perfusion systems, and perioperative policies have led to improved quality of life of the patient, lower hospitalisation costs, and lower mortality rates in the field of cardiac surgery. However, despite these improvements and improved postoperative care, the neurological outcome after cardiac surgery remains a recurrent issue of interest. The most common neurological disorders after cardiac surgery are postoperative cognitive dysfunction (POCD), cerebrovascular accident (CVA), and delirium. After conventional cardiac surgery (invasive sternotomy procedure) the incidence of these neurological disorders is well studied. POCD has an incidence of 25-50%, CVA has an incidence of 1-5% and delirium has an incidence of 5-15%. These numbers prove that neurological outcome still is a major problem after cardiac surgery.
Postoperative cognitive dysfunction (POCD) is the most common neurological disorder after cardiac surgery. POCD is defined as a disturbance of the brain function, which is causally related to surgery. Due to the multifactorial nature of POCD it is difficult to pinpoint one major cause. testing of POCD is not standardised and is based on the '1995 statement of concensus on assessment of neurobehavioural outcomes after cardiac surgery'. This consensus statement describes the most reliable tests and study design to study POCD in clinical studies.
A battery of tests is described in the consensus statement:
- Rey auditory verbal learning test for verbal memory
- Trailmaking A and B for attention
- Grooved pegboard test for fine motor function
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Minimum age of 18
- •Elective Endo-CABG procedure (group 1)
- •Elective PCI procedure (group 2)
- •Elective healthy volunteer
排除标准
- •Medical history of:
- •Postoperative cognitive dysfunction, delirium or cerebrovascular accident
- •symptomatic carotid artery disease
- •Renal dysfunction: glomular filtration rate (GFR) < 30 ml/min
- •Hepatic dysfunction: serum glutamic-oxaloacetic transaminase (SGOT)/ aspartate aminotransferase (AST), or serum glutamic-pyruvic transaminase (SGPT)/ alanine aminotransferase (ALT), more than three timer higher than normal limits
- •History of medication and alcohol abuse
- •Language barrier or incapability to communicate
- •Physical condition making participation impossible
- •Participation in other clinical trials of a drug or medical instrument
- •Surgical revision or intra-operative major cardial event (Endo-CABG group)
- •Conversion to cardiac surgery or intra-operative major event (PCI group)
结局指标
主要结局
Prevalence of cerebrovascular accident
时间窗: 3 months after intervention
percentage of total study population
Prevalence of delirium
时间窗: 3 months after intervention
percentage of total study population
Prevalence of postoperative cognitive dysfunction
时间窗: 3 months after intervention
percentage of total study population
次要结局
- assessment of predictors of poor neurological outcome after minimal invasive coronary artery bypass grafting(3 months after intervention)
- Incidence of depression after minimal invasive coronary artery bypass grafting(3 months after intervention)
- Incidence of fear after minimal invasive coronary artery bypass grafting(3 months after intervention)
- Quality of life of the patient(3 months after intervention)
研究者
Stessel Björn
MD
Jessa Hospital