Postoperative DeliriumNCT05368272
EEG Spectrogram, Brain Vulnerability and POD
An observational study of Postoperative Delirium, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
An assessment of difference in prespecified processed electroencephalography variables between cognitively intact older surgical patients who develop postoperative delirium compared to those who do not develop postoperative delirium Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Processed electroencephalography and Postoperative delirium assessment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jan 2023to 6 Dec 2023
- 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: Older people scheduled for elective major surgery at a large teaching hospital
Who may be able to join
- ≥ 65 years old
- Elective, moderate/major, non-neuro, non-cardiac surgery
- Ability to give informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EEG Spectrogram to Assess Brain Vulnerability as a Risk Factor for Postoperative Delirium in Older People - a Feasibility Study
An assessment of difference in prespecified processed electroencephalography variables between cognitively intact older surgical patients who develop postoperative delirium compared to those who do not develop postoperative delirium
Read the 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
- Conditions
- Postoperative Delirium
- Being tested
- Processed electroencephalography, Postoperative delirium assessment
- Keywords
- processed EEG, Postoperative vulnerability, Older people, Brain vulnerability
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Processed electroencephalographyOther
Acquisition of raw EEG data from processed EEG monitor. Analysis of data acquired for prespecified bandwidth properties
Postoperative delirium assessmentOther
Twice daily assessment for the incidence of postoperative delirium using validated tool (questionnaire)
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of acquiring frontal and posterior EEG data from the Narcotrend monitor during the preoperative and intraoperative period
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)
Measured: Approximately 1 - 2 hours per participant
Secondary outcomes (3)
Preoperative brain wave differences
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.
Measured: Approximately 10 minutes per participant
Change in brain wave power due to induction of anaesthesia
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)
Measured: Approximately 1 hour per particpant
Intraoperative brain wave patterns
Identify any differences in mean and spectral edge frequencies preoperatively and intraoperatively between older people who develop POD and those who do not.
Measured: Duration of surgery or 2 hours (shortest option)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start27 Jan 2023
- Primary completion6 Dec 2023
- Study completion6 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iain Moppett, FRCA, MD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368272
- Sponsor's protocol ID
- 21074
- Status last verified
- Feb 2024
- First submitted
- 5 May 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Spectrogram to Assess Brain Vulnerability as a Risk Factor for Postoperative Delirium in Older People - a Feasibility Study
- ClinicalTrials.gov ID
- NCT05368272
- Acronym / sponsor ID
- 21074
- Conditions
- Postoperative Delirium
- Keywords
- processed EEG, Postoperative vulnerability, Older people, Brain vulnerability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 10 May 2022 (actual)
- 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.
An assessment of difference in prespecified processed electroencephalography variables between cognitively intact older surgical patients who develop postoperative delirium compared to those who do not develop postoperative delirium
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older people scheduled for elective major surgery at a large teaching hospital
Key inclusion criteria (3 listed)
- ≥ 65 years old
- Elective, moderate/major, non-neuro, non-cardiac surgery
- Ability to give informed consent
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Processed electroencephalographyAcquisition of raw EEG data from processed EEG monitor. Analysis of data acquired for prespecified bandwidth properties | Other | – |
| Postoperative delirium assessmentTwice daily assessment for the incidence of postoperative delirium using validated tool (questionnaire) | Other | – |
Primary outcome
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
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)
3 secondary outcomes
Preoperative brain wave differences
Time frame: Approximately 10 minutes per participant
Change in brain wave power due to induction of anaesthesia
Time frame: Approximately 1 hour per particpant
Intraoperative brain wave patterns
Time frame: Duration of surgery or 2 hours (shortest option)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Iain Moppett, FRCA, MD principal investigator
University of Nottingham
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 Postoperative Delirium, run by University of Nottingham at 1 site in United Kingdom.
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 7 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: finished, as of the sponsor's last update on 28 Feb 2024. 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 Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024.