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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).
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delirium | 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. |
| |
| Non-delirium | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Draw | Procedure | 5 mL of blood from the patients preoperative, postoperative, 1 day and 2 days after surgery for a total of 20 mL. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing total joint arthroplasty who are 65 years of age and older.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew W Kofke, MD MBA FCCM | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11449030 | Background | Trzepacz PT, Mittal D, Torres R, Kanary K, Norton J, Jimerson N. Validation of the Delirium Rating Scale-revised-98: comparison with the delirium rating scale and the cognitive test for delirium. J Neuropsychiatry Clin Neurosci. 2001 Spring;13(2):229-42. doi: 10.1176/jnp.13.2.229. | |
| 17234823 | Background | Fong TG, Bogardus ST Jr, Daftary A, Auerbach E, Blumenfeld H, Modur S, Leo-Summers L, Seibyl J, Inouye SK. Cerebral perfusion changes in older delirious patients using 99mTc HMPAO SPECT. J Gerontol A Biol Sci Med Sci. 2006 Dec;61(12):1294-9. doi: 10.1093/gerona/61.12.1294. |
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Blood, Cerebral Spinal Fluid (CSF)
| Cerebral Spinal Fluid collection | Procedure | Fluid collected at the time of dural puncture if patients will undergo spinal anesthesia |
|
|
| Electroencephalogram | Device | Test used to detect abnormalities related to electrical activity of the brain will be done during surgery. |
|
|
| Cerebral blood flow and oxygen extraction fraction | Device | NIRS measurement of Cerebral blood flow and cerebral tissue oxygen concentration. |
|
| change from Baseline through day 2 post op |
| 9291540 | Background | Gokgoz L, Gunaydin S, Sinci V, Unlu M, Boratav C, Babacan A, Soncul H, Halit V, Inanir S, Ersoz A. Psychiatric complications of cardiac surgery postoperative delirium syndrome. Scand Cardiovasc J. 1997;31(4):217-22. doi: 10.3109/14017439709041749. |
| 2240918 | Background | Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941. |
| 5662937 | Background | Blessed G, Tomlinson BE, Roth M. The association between quantitative measures of dementia and of senile change in the cerebral grey matter of elderly subjects. Br J Psychiatry. 1968 Jul;114(512):797-811. doi: 10.1192/bjp.114.512.797. No abstract available. |
| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D004569 | Electroencephalography |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003943 | Diagnostic Techniques, Neurological |
| D004568 | Electrodiagnosis |
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