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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02818764
• Other study ID #: 822008
• Status: Terminated
• Start date: June 2016
• Est. completion date: December 2020

Study information

• Verified date: December 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Elderly
• Hip Arthroplasty

Intervention

Procedure:
• 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

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: J Neuropsychiatry Clin Neurosci 2001 Summer;13(3):433. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium Rating Scale	The severity of delirium in this patient population as quantified by the DRS	change from Baseline through day 2 post op
Primary	Serum biomarkers	The change in serum biomarkers S100ß in patients who are diagnosed with delirium by DRS.	change from Baseline through day 2 post op
Secondary	Change in cerebral blood flow	Changes in CBF from the norm in the patients who develop delirium	change from Baseline through 3 hours
Secondary	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