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TerminatedNCT02818764Updated Dec 23, 2020

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

An observational study in Delirium, Hip Arthroplasty and Elderly, sponsored by University of Pennsylvania. Terminated at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-12-23.

Sponsored by University of Pennsylvania · Observational

Why this study was terminated
COVID related limitations
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
3
Ages
65 Years and older
Sex
All
01

Study 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).

Read the detailed 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.

02

Conditions studied

  • Delirium
  • Hip Arthroplasty
  • Elderly

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Keywords

  • serum biomarkers
  • cerebral blood flow
  • modified Blessed Dementia Rating scale
  • Confusion Assessment Method
  • Delirium Rating Scale-98
03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 3 is below the median of 200 across 418 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients undergoing total joint arthroplasty who are 65 years of age and older.

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
3 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

    Procedure: Blood Draw · Procedure: Cerebral Spinal Fluid collection · Device: Electroencephalogram · Device: Cerebral blood flow and oxygen extraction fraction

  • 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.

    Procedure: Blood Draw · Procedure: Cerebral Spinal Fluid collection · Device: Electroencephalogram · Device: Cerebral blood flow and oxygen extraction fraction

Interventions

  • ProcedureBlood Draw

    5 mL of blood from the patients preoperative, postoperative, 1 day and 2 days after surgery for a total of 20 mL.

  • ProcedureCerebral Spinal Fluid collection

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

    Also known as: CSF

  • DeviceElectroencephalogram

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

    Also known as: EEG

  • DeviceCerebral blood flow and oxygen extraction fraction

    NIRS measurement of Cerebral blood flow and cerebral tissue oxygen concentration.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. 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

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Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

References and documents

Publications

  • 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. Erratum In: J Neuropsychiatry Clin Neurosci 2001 Summer;13(3):433. PubMed 11449030 ↗
  • 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. PubMed 17234823 ↗
  • 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. PubMed 9291540 ↗
  • 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. PubMed 2240918 ↗
  • 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. PubMed 5662937 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02818764
Lead sponsor
University of Pennsylvania
Responsible party
Sponsor
First posted
Jun 30, 2016
Start date
Jun 2016
Primary completion
Dec 2020
Completion
Dec 2020
Last update
Dec 23, 2020

Study contacts

Andrew W Kofke, MD MBA FCCM
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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