Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02818764
Recruitment Status : Terminated (COVID related limitations)
First Posted : June 30, 2016
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief 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).

Condition or disease Intervention/treatment
Delirium Hip Arthroplasty Elderly Procedure: Blood Draw Procedure: Cerebral Spinal Fluid collection Device: Electroencephalogram Device: Cerebral blood flow and oxygen extraction fraction

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Pathophysiology of Delirium in Patients Undergoing Total Hip Arthroplasty: Role of Intraoperative Cerebral Perfusion and EEG Abnormalities
Study Start Date : June 2016
Actual Primary Completion Date : December 2020
Actual Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

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

Procedure: Cerebral Spinal Fluid collection
Fluid collected at the time of dural puncture if patients will undergo spinal anesthesia
Other Name: CSF

Device: Electroencephalogram
Test used to detect abnormalities related to electrical activity of the brain will be done during surgery.
Other Name: EEG

Device: 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.

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.

Procedure: Cerebral Spinal Fluid collection
Fluid collected at the time of dural puncture if patients will undergo spinal anesthesia
Other Name: CSF

Device: Electroencephalogram
Test used to detect abnormalities related to electrical activity of the brain will be done during surgery.
Other Name: EEG

Device: Cerebral blood flow and oxygen extraction fraction
NIRS measurement of Cerebral blood flow and cerebral tissue oxygen concentration.




Primary Outcome Measures :
  1. Delirium Rating Scale [ Time Frame: change from Baseline through day 2 post op ]
    The severity of delirium in this patient population as quantified by the DRS

  2. Serum biomarkers [ Time Frame: change from Baseline through day 2 post op ]
    The change in serum biomarkers S100β in patients who are diagnosed with delirium by DRS.


Secondary Outcome Measures :
  1. Change in cerebral blood flow [ Time Frame: change from Baseline through 3 hours ]
    Changes in CBF from the norm in the patients who develop delirium

  2. Confusion Assessment Method [ Time Frame: change from Baseline through day 2 post op ]
    Changes in patient performance to determine the presence or absence of delirium as measured by the CAM test


Biospecimen Retention:   Samples With DNA
Blood, Cerebral Spinal Fluid (CSF)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing total joint arthroplasty who are 65 years of age and older.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02818764


Locations
Layout table for location information
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Layout table for investigator information
Principal Investigator: Andrew W Kofke, MD MBA FCCM University of Pennsylvania
Publications:
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02818764    
Other Study ID Numbers: 822008
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020
Keywords provided by University of Pennsylvania:
serum biomarkers
cerebral blood flow
modified Blessed Dementia Rating scale
Confusion Assessment Method
Delirium Rating Scale-98
Additional relevant MeSH terms:
Layout table for MeSH terms
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders