DeliriumNCT02818764
Delirium, Intraoperative Cerebral Perfusion and EEG Abnormalities After Total Hip Arthroplasty
An observational study of Delirium and Hip Arthroplasty, run by University of Pennsylvania at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium, Hip Arthroplasty, Elderly
- What is being tested?
- Blood Draw, Cerebral Spinal Fluid collection and Electroencephalogram
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients undergoing total joint arthroplasty who are 65 years of age and older.
Who may be able to join
- Patients 65 years of age and over scheduled for elective total joint arthroplasty
- Mentally competent and able to give consent for enrollment in the study
- Patients at any age with a pre-existing diagnosis of dementia or acquired cognitive deficit. Consented by legally authorized representative (LAR).
Who cannot join
- Patients currently delirious
- Acute neurological disease like stroke or brain tumor
- Current alcohol or substance abuse at risk of postoperative withdrawal
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Pathophysiology of Delirium in Patients Undergoing Total Hip Arthroplasty: Role of Intraoperative Cerebral Perfusion and EEG Abnormalities
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.
- The 3D -Confusion Assessment Method (CAM) test is a clinician evaluation and algorithm for the binary determination of presence or absence of delirium.
- 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
- Delirium, Hip Arthroplasty, Elderly
- Being tested
- Blood Draw, Cerebral Spinal Fluid collection, Electroencephalogram, Cerebral blood flow and oxygen extraction fraction
- Keywords
- serum biomarkers, cerebral blood flow, modified Blessed Dementia Rating scale, Confusion Assessment Method, Delirium Rating Scale-98
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawProcedure or surgery
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 or surgery
Also called CSF
Fluid collected at the time of dural puncture if patients will undergo spinal anesthesia
ElectroencephalogramDevice
Also called EEG
Test used to detect abnormalities related to electrical activity of the brain will be done during surgery.
Cerebral blood flow and oxygen extraction fractionDevice
NIRS measurement of Cerebral blood flow and cerebral tissue oxygen concentration.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Blood Draw; Procedure: Cerebral Spinal Fluid collection; Device: Electroencephalogram; Device: Cerebral blood flow and oxygen extraction fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium Rating Scale
The severity of delirium in this patient population as quantified by the DRS
Measured: 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.
Measured: change from Baseline through day 2 post op
Secondary outcomes (2)
Change in cerebral blood flow
Changes in CBF from the norm in the patients who develop delirium
Measured: 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
Measured: change from Baseline through day 2 post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2020
- Study completionDec 2020
Why it stopped: COVID related limitations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew W Kofke, MD MBA FCCM, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818764
- Sponsor's protocol ID
- 822008
- Status last verified
- Dec 2020
- First submitted
- 2 Jun 2016
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 11449030Fong 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 17234823Gokgoz 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 9291540Inouye 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 2240918Blessed 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiology of Delirium in Patients Undergoing Total Hip Arthroplasty: Role of Intraoperative Cerebral Perfusion and EEG Abnormalities
- ClinicalTrials.gov ID
- NCT02818764
- Acronym / sponsor ID
- 822008
- Conditions
- Delirium, Hip Arthroplasty, Elderly
- Keywords
- serum biomarkers, cerebral blood flow, modified Blessed Dementia Rating scale, Confusion Assessment Method, Delirium Rating Scale-98
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID related limitations
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
- The 3D -Confusion Assessment Method (CAM) test is a clinician evaluation and algorithm for the binary determination of presence or absence of delirium.
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delirium | – | Procedure: Blood Draw, Procedure: Cerebral Spinal Fluid collection, Device: Electroencephalogram, Device: Cerebral blood flow and oxygen extraction fractionSubjects 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. |
| Non-delirium | – | Procedure: Blood Draw, Procedure: Cerebral Spinal Fluid collection, Device: Electroencephalogram, Device: Cerebral blood flow and oxygen extraction fractionSubjects 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients undergoing total joint arthroplasty who are 65 years of age and older.
Key inclusion criteria (3 listed)
- Patients 65 years of age and over scheduled for elective total joint arthroplasty
- Mentally competent and able to give consent for enrollment in the study
- Patients at any age with a pre-existing diagnosis of dementia or acquired cognitive deficit. Consented by legally authorized representative (LAR).
Key exclusion criteria (3 listed)
- Patients currently delirious
- Acute neurological disease like stroke or brain tumor
- Current alcohol or substance abuse at risk of postoperative withdrawal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Draw5 mL of blood from the patients preoperative, postoperative, 1 day and 2 days after surgery for a total of 20 mL. | Procedure or surgery | Delirium, Non-delirium |
| Cerebral Spinal Fluid collectionAlso: CSFFluid collected at the time of dural puncture if patients will undergo spinal anesthesia | Procedure or surgery | Delirium, Non-delirium |
| ElectroencephalogramAlso: EEGTest used to detect abnormalities related to electrical activity of the brain will be done during surgery. | Device | Delirium, Non-delirium |
| Cerebral blood flow and oxygen extraction fractionNIRS measurement of Cerebral blood flow and cerebral tissue oxygen concentration. | Device | Delirium, Non-delirium |
Primary outcome
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
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.
2 secondary outcomes
Change in cerebral blood flow
Time frame: change from Baseline through 3 hours
Confusion Assessment Method
Time frame: change from Baseline through day 2 post op
Results and safety
The study was stopped early (reason given: COVID related limitations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Background: PubMed 11449030Trzepacz 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.
- Background: PubMed 17234823Fong 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.
- Background: PubMed 9291540Gokgoz 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.
- Background: PubMed 2240918Inouye 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.
- Background: PubMed 5662937Blessed 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew W Kofke, MD MBA FCCM principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Hip Arthroplasty, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID related limitations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium Rating Scale (time frame: change from Baseline through day 2 post op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02818764, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.