- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05368272
EEG Spectrogram, Brain Vulnerability and POD
EEG Spectrogram to Assess Brain Vulnerability as a Risk Factor for Postoperative Delirium in Older People - a Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postoperative delirium in older people may be contributed to by intrinsic brain vulnerability such as pre-existing dementia. Some cognitively intact older people also experience postoperative delirium and in these patients some go on to develop later dementia. The investigators propose that postoperative delirium may be an unmasking of covert brain vulnerability by the dyshomeostasis of the anaesthesia/surgical intervention.
In people with dementia or mild cognitive impairment, electroencephalography (EEG) studies have shown slowing of brain wave activity, especially in the back of the brain.
Processed electroencephalography, using a limited number of channels, is routinely used during anaesthesia to aid assessment of anaesthetic depth of the patient.
In this study the investigators will assess the feasibility of acquiring EEG data from the front and back of the brain. The investigators will also explore the data for early signals of brain vulnerability
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nottingham, United Kingdom
- Queen's Medical Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥ 65 years old
- Elective, moderate/major, non-neuro, non-cardiac surgery
- Ability to give informed consent
Exclusion Criteria:
- Preoperative cognitive impairment
- Current systemic infection
- Current use of medication that may modify EEG
- History of neurosurgery/significant head trauma
- Presence of neurological diseases including overt stroke, dementia, epilepsy, multiple sclerosis, Parkinson's disease, intracranial tumours and other significant neurologic disorders
- Current significant psychiatric conditions such as severe depression.
- Palliative surgery
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feasibility of acquiring frontal and posterior EEG data from the Narcotrend monitor during the preoperative and intraoperative period
Time Frame: Approximately 1 - 2 hours per participant
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Feasibility will be assessed by the ability to get preoperative and intraoperative epochs of EEG that clearly demonstrates the different brain wave bands (alpha, theta and delta)
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Approximately 1 - 2 hours per participant
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preoperative brain wave differences
Time Frame: Approximately 10 minutes per participant
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Identify any differences in frontal and posterior narrowband (i.e.
alpha, delta and theta) power preoperatively between older people who develop POD compared to those who do not.
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Approximately 10 minutes per participant
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Change in brain wave power due to induction of anaesthesia
Time Frame: Approximately 1 hour per particpant
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Identify if the change in narrowband power from the preoperative values to steady state intraoperative values are different between groups (i.e.
people who develop POD vs people who do not develop POD)
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Approximately 1 hour per particpant
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Intraoperative brain wave patterns
Time Frame: Duration of surgery or 2 hours (shortest option)
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Identify any differences in mean and spectral edge frequencies preoperatively and intraoperatively between older people who develop POD and those who do not.
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Duration of surgery or 2 hours (shortest option)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Iain Moppett, FRCA, MD, University of Nottingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21074
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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