Assessing the Incidence of Postoperative Delirium Following Aortic Valve Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Number of Participants With Postoperative Delirium
研究概览
简要总结
Our primary aim in this observational study is to identify the incidence of POD in the first five postoperative days by using the 3-minute Diagnostic confusion assessment method (3D-CAM), the derived version for intensive care unit (CAM-ICU) or nurse reports in patients undergoing different techniques of aortic valve replacement. Patients are followed 5 days postoperative with the 3D-CAM or until resolution of POD. Six months postoperatively, a follow-up by phone is planned for activity of daily living (ADL).
详细描述
A significant and often underrecognized complication after surgery is postoperative delirium (POD) causing increased morbidity and mortality. This is especially true for the older cardiac surgical patient, in whom the incidence of POD is up to 70%. Surgical invasiveness and herewith related inflammation, a cholinergic load of medications, postoperative pain or use of opioids are examples of precipitating factors that can be altered to reduce the incidence of POD. Transaortic valve replacement (TAVR) is a revolutionary technique that has led to a dramatic decrease in surgical invasiveness and improved outcomes in high-risk surgical patients. However, only a few studies evaluated neurocognitive outcome after surgical aortic valve replacement (SAVR) compared to TAVR, suggesting a reduced incidence of POD with TAVR compared to SAVR. In contrast, other studies found almost no difference in POD in the aforementioned patient groups. Hence, it remains still unclear which technique best to use in patients at high risk for POD.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo elective
- •SAVR (with or without coronary artery bypass grafting (CABG) or pulmonary vein isolation (PVI))
- •Patient able to read and understand the research materials
排除标准
- •Inability to give informed consent
- •Presence of delirium at baseline as screened with the 3-minute Diagnostic Confusion Assessment Method (3D-CAM)
- •Combined surgical procedures (e.g. mitral valve surgery, aortic surgery or other)
结局指标
主要结局
Number of Participants With Postoperative Delirium
时间窗: Until the fifth postoperative day in hospital (an average of 5 days). In case of POD, followup was continued until resolution of POD or discharge (whichever comes first) up to 19 days.
Using the 3-minute Diagnostic confusion assessment method (3D-CAM), the derived version for intensive care unit (CAM-ICU) and nurse reports combined with interview with the caregivers and patient
次要结局
- Number of Patients With Adverse Events According to the Composite Endpoint Early Safety According to VARC-2 at 30 Days(Until 30 days postoperatively)
- Intensive Care Unit (ICU) Length of Stay(Until 30 days postoperatively)
- Duration of POD(If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge)
- Assessment of Instrumental Activities of Daily Living During 6-months Interview(6 months postoperatively)
- Hospital Length of Stay(Until 30 days postoperatively)
- Onset Moment of Postoperative Delirium(During the first five postoperative days)
- Severity of POD(If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge)
- Count of Patients Discharged Directly Home(Until 30 days postoperatively)
- Number of Patients With Adverse Events According to the Composite Endpoint Clinical Efficacy According to VARC-2 at 6 Months(6 months)
研究者
dr. Danny Hoogma
Anesthesiologist
Universitaire Ziekenhuizen KU Leuven