Delirium, Intraoperative Cerebral Perfusion and EEG Abnormalities After Total Hip Arthroplasty

Study Overview
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Brief Summary
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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).

Detailed Description
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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. The investigators will be drawing blood from patients who agree to participate in the study. Preoperative blood sampling will be done while the investigators place the intravenous line, or if present, from an arterial line. If a spinal anesthetic is being used, 5 mL of cerebral spinal fluid (CSF) will be collected at the time of dural puncture prior to the administration of the neuraxial blockade. Members of the research team will administer 3D-CAM testing on post-operative days 1 and 2.

Official Title
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Pathophysiology of Delirium in Patients Undergoing Total Hip Arthroplasty: Role of Intraoperative Cerebral Perfusion and EEG Abnormalities

Conditions
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Delirium, Hip Arthroplasty, Elderly

Intervention / Treatment
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* Procedure: Blood Draw
* Procedure: Cerebral Spinal Fluid collection
* Device: Electroencephalogram
* Device: Cerebral blood flow and oxygen extraction fraction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: Patients currently delirious Acute neurological disease like stroke or brain tumor Current alcohol or substance abuse at risk of postoperative withdrawal

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Delirium<br>Subjects undergoing elective total joint arthroplasty determined to have delirium by post operative 3D-CAM. Data collected on intraoperative cerebral blood flow and oxygen extraction fraction. CSF collected for biomarkers. Blood colelcted for biomarkers. | Procedure: Blood Draw<br>* 5 mL of blood from the patients preoperative, postoperative, 1 day and 2 days after surgery for a total of 20 mL.<br>Procedure: Cerebral Spinal Fluid collection<br>* Fluid collected at the time of dural puncture if patients will undergo spinal anesthesia<br>* Other names: CSF;Device: Electroencephalogram<br>* Test used to detect abnormalities related to electrical activity of the brain will be done during surgery.<br>* Other names: EEG;Device: Cerebral blood flow and oxygen extraction fraction<br>* NIRS measurement of Cerebral blood flow and cerebral tissue oxygen concentration.<br>|
| Non-delirium<br>Subjects undergoing elective total joint arthroplasty determined not to have delirium by post oeprative 3D-CAM. Data collected on intraoperative cerebral blood flow and oxygen extraction fraction. CSF collected for biomarkers. Blood colelcted for biomarkers. | Procedure: Blood Draw<br>* 5 mL of blood from the patients preoperative, postoperative, 1 day and 2 days after surgery for a total of 20 mL.<br>Procedure: Cerebral Spinal Fluid collection<br>* Fluid collected at the time of dural puncture if patients will undergo spinal anesthesia<br>* Other names: CSF;Device: Electroencephalogram<br>* Test used to detect abnormalities related to electrical activity of the brain will be done during surgery.<br>* Other names: EEG;Device: Cerebral blood flow and oxygen extraction fraction<br>* NIRS measurement of Cerebral blood flow and cerebral tissue oxygen concentration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium Rating Scale | The severity of delirium in this patient population as quantified by the DRS | change from Baseline through day 2 post op | 
| Serum biomarkers | The change in serum biomarkers S100β in patients who are diagnosed with delirium by DRS. | change from Baseline through day 2 post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cerebral blood flow | Changes in CBF from the norm in the patients who develop delirium | change from Baseline through 3 hours | 
| Confusion Assessment Method | Changes in patient performance to determine the presence or absence of delirium as measured by the CAM test | change from Baseline through day 2 post op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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serum biomarkers, cerebral blood flow, modified Blessed Dementia Rating scale, Confusion Assessment Method, Delirium Rating Scale-98