Delirium, Intraoperative Cerebral Perfusion and EEG Abnormalities After Total Hip Arthroplasty
NCT ID: NCT02818764
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
3 participants
OBSERVATIONAL
2016-06-30
2020-12-31
Brief Summary
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Detailed Description
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Each patient will have a preoperative baseline 3D-CAM and MOCA to document preoperative cognitive function and possible criteria for exclusion.
1. The 3D -Confusion Assessment Method (CAM) test is a clinician evaluation and algorithm for the binary determination of presence or absence of delirium.
2. 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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Blood Draw
5 mL of blood from the patients preoperative, postoperative, 1 day and 2 days after surgery for a total of 20 mL.
Cerebral Spinal Fluid collection
Fluid collected at the time of dural puncture if patients will undergo spinal anesthesia
Electroencephalogram
Test used to detect abnormalities related to electrical activity of the brain will be done during surgery.
Cerebral blood flow and oxygen extraction fraction
NIRS measurement of Cerebral blood flow and cerebral tissue oxygen concentration.
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.
Blood Draw
5 mL of blood from the patients preoperative, postoperative, 1 day and 2 days after surgery for a total of 20 mL.
Cerebral Spinal Fluid collection
Fluid collected at the time of dural puncture if patients will undergo spinal anesthesia
Electroencephalogram
Test used to detect abnormalities related to electrical activity of the brain will be done during surgery.
Cerebral blood flow and oxygen extraction fraction
NIRS measurement of Cerebral blood flow and cerebral tissue oxygen concentration.
Interventions
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Blood Draw
5 mL of blood from the patients preoperative, postoperative, 1 day and 2 days after surgery for a total of 20 mL.
Cerebral Spinal Fluid collection
Fluid collected at the time of dural puncture if patients will undergo spinal anesthesia
Electroencephalogram
Test used to detect abnormalities related to electrical activity of the brain will be done during surgery.
Cerebral blood flow and oxygen extraction fraction
NIRS measurement of Cerebral blood flow and cerebral tissue oxygen concentration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Mentally competent and able to give consent for enrollment in the study
3. Patients at any age with a pre-existing diagnosis of dementia or acquired cognitive deficit. Consented by legally authorized representative (LAR).
Exclusion Criteria
2. Acute neurological disease like stroke or brain tumor
3. Current alcohol or substance abuse at risk of postoperative withdrawal
65 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Andrew W Kofke, MD MBA FCCM
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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822008
Identifier Type: -
Identifier Source: org_study_id