Cerebral Blood Flow During CPB During Cardiac Surgery and the Presence of Post op Delirium
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)
研究概览
地位
条件
详细说明
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
研究类型
注册 (实际的)
联系人和位置
学习地点
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Maryland
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Baltimore、Maryland、美国、21287
- Johns Hopkins Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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-
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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no intervention
Contact with enrolled subjects requires application of ceberal oximetry electrodes and the concommittent ultrasound of the temporal artery.
Deemed interventional by JHUIRB but no actual intervention done to subject.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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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
大体时间：3 days post op
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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.
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3 days post op
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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recovery pattern of rSO2
大体时间：3 post op days
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To evaluate the recovery pattern of rSO2 and CBF for up to 6 hrs after CPB for ICU patients who experience delirium within three days after cardiac surgery compared with patients without delirium.
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3 post op days
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Can CBF autoregulation can be monitored using ultrasound compared with TCD
大体时间：3 days post op
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To assess whether CBF autoregulation can be monitored using ultrasound tagged light methodology compared with TCD
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3 days post op
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To evaluate the incidence of delirium in patients with impaired autoregulation
大体时间：3 days post op
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To evaluate the incidence of delirium in patients with impaired autoregulation
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3 days post op
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合作者和调查者
合作者
调查人员
- 首席研究员：Kaushik Mandal, MD、Johns Hopkins University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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