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

University of Pennsylvania3 enrolled

Overview

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. 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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Delirium Hip Arthroplasty Elderly

Interventions

Blood DrawPROCEDURE

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 collectionPROCEDURE

Fluid collected at the time of dural puncture if patients will undergo spinal anesthesia

ElectroencephalogramDEVICE

Test used to detect abnormalities related to electrical activity of the brain will be done during surgery.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients 65 years of age and over scheduled for elective total joint arthroplasty 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: 1. Patients currently delirious 2. Acute neurological disease like stroke or brain tumor 3. Current alcohol or substance abuse at risk of postoperative withdrawal

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Delirium Rating Scale

The severity of delirium in this patient population as quantified by the DRS

Time frame: 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.

Time frame: change from Baseline through day 2 post op

Secondary Outcomes

Change in cerebral blood flow

Changes in CBF from the norm in the patients who develop delirium

Time frame: 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

Time frame: change from Baseline through day 2 post op

Data from ClinicalTrials.gov

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