Non Invasive Monitoring of Cerebral Blood Flow During and After Cardiopulmonary Bypass to Assess and Compare for the Presence of Delirium in Post Operative Patients (DELIRIUM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To evaluate whether rSO2 and/or CBF during CPB is lower in patients who experience delirium within three days after cardiac surgery compared with patients without delirium
研究概览
简要总结
Cardiac surgery is associated with multiple events and issues that increase risk for adverse postoperative neurological outcomes including postoperative cognitive dysfunction. The risk for postoperative delirium is generally thought to result from some previous health factors added to the susceptibility of the cardiac surgery process.
详细描述
Cardiac surgery is associated with multiple perturbations that increase risk for adverse postoperative neurological outcomes including postoperative cognitive dysfunction. These same perturbations likely also increase the risk for postoperative delirium although there are little data that have evaluated this hypothesis.
As the subject is prepared for surgery 2 contact probes will be placed on the forehead to monitor the rSO2 and cerebral blood flow. This monitor can also measureblood flow velocity in blood vessels in the forehead.
This will only be done while the subject is on the cardiac bypass machine during the surgery and end shortly after entering the intensive care unit.Prior to surgery and then once a day on three of the first four postoperative days, patients will be assessed for the presence and severity of delirium with brief standard psychological exams. We will compare rSO2 and CBF changes between patients with and without delirium
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in the study will be 50 or older undergoing elective cardiovascular surgery using cardiopulmonary bypass.
- •Patients who can speak, read and understand the English language.
- •Patients who understand the nature of the study and are willing to sign the consent form
排除标准
- •Emergency surgery or patients intubated before surgery and, thus, cannot give informed consent.
- •Patients diagnosed with neurocognitive disorders (e.g. Alzheimer's, Dementia)
- •MMSE score greater than 21 Patients taking antipsychotic drugs A history of drug abuse
- •Patients with an implant in the brain underneath the CerOx probes
- •Women who are pregnant.
- •History of significant, prohibitive skin allergies or reactions-
结局指标
主要结局
To evaluate whether rSO2 and/or CBF during CPB is lower in patients who experience delirium within three days after cardiac surgery compared with patients without delirium
时间窗: 3 days post op
To evaluate whether rSO2 and/or CBF during CPB is lower in patients who experience delirium within three days after cardiac surgery compared with patients without delirium.
次要结局
- recovery pattern of rSO2(3 post op days)
研究者
Dr Kaushik Mandal
Assistant Professor Division of Cardiac Surgery
Johns Hopkins University