Pathophysiology of Delirium in Patients Undergoing Total Hip Arthroplasty: Role of Intraoperative Cerebral Perfusion and EEG Abnormalities
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Delirium Rating Scale
研究概览
简要总结
The overall objective of this study is to test for perturbations in intraoperative electroencephalogram (EEG) , cerebral blood flow (CBF), cerebral metabolic rate of oxygen consumption (CMRO2), oxygen extraction fraction (OEF), and serum and cerebral spinal fluid biomarkers associated with delirium in high risk population having elective hip arthroplasty at Penn Presbyterian Medical Center (PPMC).
详细描述
All prospective patients will be given a copy of the informed consent which explains the details and responsibilities of the study.
Each patient will have a preoperative baseline 3D-CAM and MOCA to document preoperative cognitive function and possible criteria for exclusion.
- The 3D -Confusion Assessment Method (CAM) test is a clinician evaluation and algorithm for the binary determination of presence or absence of delirium.
- Montreal Confusion Assessment (MOCA) - to be given preoperatively to determine if element of pre-existing cognitive impairment
Intraoperatively each patient will have a NIR Optode patch placed to measure intraoperative cerebral blood flow and oxygen extraction fraction and cerebral metabolic rate of oxygen consumption.
A non-invasive frontal EEG patch will be placed prior to or at the start of anesthesia. Anesthetic depth will be measured using the SEDline® by Masimo. Continuous raw EEG, spectral edge, compressed spectral analysis and percentage suppressed will be recorded from the SEDline® monitor.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients 65 years of age and over scheduled for elective total joint arthroplasty
- •Mentally competent and able to give consent for enrollment in the study
- •Patients at any age with a pre-existing diagnosis of dementia or acquired cognitive deficit. Consented by legally authorized representative (LAR).
排除标准
- •Patients currently delirious
- •Acute neurological disease like stroke or brain tumor
- •Current alcohol or substance abuse at risk of postoperative withdrawal
结局指标
主要结局
Delirium Rating Scale
时间窗: change from Baseline through day 2 post op
The severity of delirium in this patient population as quantified by the DRS
Serum biomarkers
时间窗: change from Baseline through day 2 post op
The change in serum biomarkers S100β in patients who are diagnosed with delirium by DRS.
次要结局
- Change in cerebral blood flow(change from Baseline through 3 hours)
- Confusion Assessment Method(change from Baseline through day 2 post op)