Incidence and Risk Factors of Acute Postoperative Confusion State After Trans-catheter Aortic Valve Implantation (TAVI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Incidence of delirium
研究概览
简要总结
Patients undergoing transcatheter aortic valve implantation (TAVI) have distinctive characteristics: they are old, frail, with several co-morbidities and take multiple medications. Hemodynamic instability, cerebral embolism, sedation, general anesthesia and hospitalization in intensive care expose those patients to postprocedural delirium.
Acute neurocognitive dysfunctions are associated with adverse outcomes in these population.
The objective of this study is to determine the incidence of delirium and neurocognitive disorders in elderly patients after TAVI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age 65>years
- •Patients undergoing transcatheter aortic valve implantation
- •Patients have given informed consent for participation at the study
排除标准
- •Patient suffering from delirium (CAM diagnosis) at recruitment
- •Inability to understand the national languages
- •Emergency procedures
结局指标
主要结局
Incidence of delirium
时间窗: Day 1-5 after transcatheter aortic valve implantation
The primary outcome is incidence of delirium. Delirium screening will be carry out using the CAM or CAM-ICU in accordance with local hospital clinical delirium-screening guidelines. The assessment of presence of Delirium will be perform by clinician with CAM in agreement with Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM IV). CAM is standardized method to enable non-psychiatrically trained clinicians to identify delirium and assesses nine features of delirium: (1) acute onset, (2) inattention, (3) disorganized thinking, (4) altered level of consciousness, (5) disorientation, (6) memory impairment, (7) perceptual disturbances, (8) psychomotor agitation or retardation and (9) altered sleep-wake cycle. Delirium is diagnosed when feature 1 and 2 are present and either 3 or 4 are displayed.
次要结局
- Mortality(30-days, 3-months and 1 year)
- Type of delirium(Day 1-5 after transcatheter aortic valve implantation)
- Risk factors for postoperative delirium(Baseline, intra-operative and days 1-5 after transcatheter aortic valve implantation)
- Onset of delirium(Day 1-5 after transcatheter aortic valve implantation)
- Complications of delirium(Day 1-5 after transcatheter aortic valve implantation)
- Trajectories of functional abilities(Changes from baseline up to 5 day and 3-months)
- Trajectories of neurocognitive function(Changes from baseline up to 5 day and 3-months)
研究者
Tiziano Cassina
Tiziano Cassina, MD
Cardiocentro Ticino