Observational Study on the Predictive Value of the BAMCOG and Cortisol Levels for the Incidence of Postoperative Delirium/Postoperative Acute Encephalopathy Measured by the MoCA and the DeltaScan in Patients Who Undergo Aortic Valve Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Prognostic value of the preoperative BAMCOG to predict postoperative delirium
研究概览
简要总结
There is lack of attention to preoperative cognitive function and delirium in elderly who underwent surgery. The investigators are investigating different tools that can help to screen for cognitive dysfunction and delirium in the future.
详细描述
Background of the study:
The mean age of surgical patients is rising worldwide and this is associated with more multi-morbidity. Especially geriatric patients who undergo surgery have a higher risk to develop Postoperative Cognitive Dysfunction or a Postoperative Delirium, which leads to higher morbidity and mortality after surgery and this leads to higher healthcare costs.
A delirium is an acutely disturbed state of mind characterized by restlessness, illusions, and incoherence, occurring in intoxication, fever, and other disorders and can fluctuate over time. The hypoactive delirium, the most common type of delirium, is hard to recognize compared to the active delirium that is expressed by restlessness and agitation.
Postoperative cognitive dysfunction is defined as a new cognitive impairment arising after a surgical procedure. Its diagnosis requires both pre- and postoperative psychometric testing. Its manifestations are subtle and manifold, depending on the particular cognitive domains that are affected, and therefore hard to recognize too.
To assess preoperative cognitive function in large groups of patients, it's needed to have a simple and quick tool to screen. In this study, the investigators use the BAMCOG, which is a tool with 3 short games played on a tablet that can provide information about cognitive functioning. When writing this new study protocol, a validation study in which the BAMCOG is validated against the MoCA is running.
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 120 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age >65 year
- •scheduled for AVR surgery
- •Able to play the BAMCOG games after instruction
- •(Near) native (dutch)
排除标准
- •mental disorder
- •learning disorder
- •diagnosed dementia at start of study
- •alcohol abuses
- •lithium/clozapine use because of DeltaScan
- •sedation/RASS -4/-5 because of DeltaScan
- •not able to sign informed consent
- •implanted pacemaker, defibrillator or neurostimulator because of pilocarpine iontophoresis
- •history of insults
- •pregnant women
- •allergy to pilocarpine
- •damaged skin (forearm)
结局指标
主要结局
Prognostic value of the preoperative BAMCOG to predict postoperative delirium
时间窗: BAMCOG and DeltaScan - preoperative 1 day, postoperative day 1, 3, 7.
次要结局
- Correlation BAMCOG scores and MoCA scores(MoCA - preoperative 1 day, postoperative day 1, 3, 7)
- Prognostic value of cortisol measures (Sweat, Saliva, Serum) to predict postoperative delirium(Preoperative at home and postoperative day 1)
研究者
Mariska te Pas
Principal Investigator
Catharina Ziekenhuis Eindhoven
