DeliriumNCT05209555
Preoperative BAMCOG and Cortisol and Postoperative DeltaScan in AVR Patients (Aortic Valve Replacement)
An observational study of Delirium and Cognitive Impairment, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
There is lack of attention to preoperative cognitive function and delirium in elderly who underwent surgery. The investigators are investigating different tools that can help to screen for cognitive dysfunction and delirium in the future. Read more about this study
- Who is it for?
- Ages 65 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Delirium, Cognitive Impairment, Cognitive Dysfunction
- What is being tested?
- MoCA, BAMCOG and DeltaScan
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Jan 2022to 31 Dec 2022
- 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 to 120 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: 50 patients 65 years or older who will undergo AVR-bio surgery
Who may be able to join
- age >65 year
- scheduled for AVR surgery
- Able to play the BAMCOG games after instruction
- (Near) native (dutch)
Who cannot join
- mental disorder
- learning disorder
- diagnosed dementia at start of study
- alcohol abuses
- lithium/clozapine use because of DeltaScan
- sedation/RASS -4/-5 because of DeltaScan
Show all 12Show fewer
- not able to sign informed consent
- implanted pacemaker, defibrillator or neurostimulator because of pilocarpine iontophoresis
- history of insults
- pregnant women
- allergy to pilocarpine
- damaged skin (forearm)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on the Predictive Value of the BAMCOG and Cortisol Levels for the Incidence of Postoperative Delirium/Postoperative Acute Encephalopathy Measured by the MoCA and the DeltaScan in Patients Who Undergo Aortic Valve Replacement Surgery
There is lack of attention to preoperative cognitive function and delirium in elderly who underwent surgery. The investigators are investigating different tools that can help to screen for cognitive dysfunction and delirium in the future.
Read the detailed description
Background of the study:
The mean age of surgical patients is rising worldwide and this is associated with more multi-morbidity. Especially geriatric patients who undergo surgery have a higher risk to develop Postoperative Cognitive Dysfunction or a Postoperative Delirium, which leads to higher morbidity and mortality after surgery and this leads to higher healthcare costs.
A delirium is an acutely disturbed state of mind characterized by restlessness, illusions, and incoherence, occurring in intoxication, fever, and other disorders and can fluctuate over time. The hypoactive delirium, the most common type of delirium, is hard to recognize compared to the active delirium that is expressed by restlessness and agitation.
Postoperative cognitive dysfunction is defined as a new cognitive impairment arising after a surgical procedure. Its diagnosis requires both pre- and postoperative psychometric testing. Its manifestations are subtle and manifold, depending on the particular cognitive domains that are affected, and therefore hard to recognize too.
To assess preoperative cognitive function in large groups of patients, it's needed to have a simple and quick tool to screen. In this study, the investigators use the BAMCOG, which is a tool with 3 short games played on a tablet that can provide information about cognitive functioning. When writing this new study protocol, a validation study in which the BAMCOG is validated against the MoCA is running.
Beside the BAMCOG, another instrument will be investigated. The DeltaScan is an EEG delta waves measurement to identify patients with a (hypoactive) delirium. Delta waves are slow brainwaves that have been seen in sedated patients and even inpatients with an active or hypoactive delirium. A study of Kimchi et al. studied whether routine clinical EEG findings, including slowing, are correlated with delirium severity in a heterogeneous population with various causes of altered mental status and found that generalized slowing on routine clinical EEG strongly correlates with delirium and may be a valuable biomarker for delirium severity (OR 7.4, 95% CI 3.8-14.4).
A lot remains unclear about the biological mechanisms in the development of a delirium after surgery, although in literature are directions that inflammatory reactions and the neuro-endocrine system play an important role. That is the reason for investigating the relation between cortisol levels in blood, saliva and sweat and the development of postoperative acute encephalopathy.
Objective of the study:
- The predictive value of the BAMCOG for developing postoperative delirium/postoperative acute encephalopathy in patients who underwent AVR surgery
- Concurrent validation of the BAMCOG with the MoCA
- The relation between cortisol levels in blood, saliva and sweat and the development of postoperative delirium/postoperative acute encephalopathy.
- Conditions
- Delirium, Cognitive Impairment, Cognitive Dysfunction, Cognitive Dysfunction, Postoperative, Delirium in Old Age, Postoperative Delirium
- Being tested
- MoCA, BAMCOG, DeltaScan, Salivette, Pilocarpine iontophoresis
- Medical subject headings
- Delirium, Cognitive Dysfunction, Postoperative Cognitive Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoCADiagnostic test
MoCA test to identify Mild Cognitive Impairment
BAMCOGDevice
Three games, compared to the MoCA to identify Mild Cognitive Impairment
DeltaScanDiagnostic test
EEG to detect acute encephalopathy
SalivetteDiagnostic test
To collect saliva for cortisol analysis
Pilocarpine iontophoresisDiagnostic test
To collect sweat for cortisol analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic value of the preoperative BAMCOG to predict postoperative delirium
Measured: BAMCOG and DeltaScan - preoperative 1 day, postoperative day 1, 3, 7.
Secondary outcomes (2)
Correlation BAMCOG scores and MoCA scores
Measured: MoCA - preoperative 1 day, postoperative day 1, 3, 7
Prognostic value of cortisol measures (Sweat, Saliva, Serum) to predict postoperative delirium
Measured: Preoperative at home and postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start10 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariska te Pas, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209555
- Sponsor's protocol ID
- CZE-2021.57
- Status last verified
- Apr 2023
- First submitted
- 13 Jan 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Predictive Value of the BAMCOG and Cortisol Levels for the Incidence of Postoperative Delirium/Postoperative Acute Encephalopathy Measured by the MoCA and the DeltaScan in Patients Who Undergo Aortic Valve Replacement Surgery
- ClinicalTrials.gov ID
- NCT05209555
- Acronym / sponsor ID
- CZE-2021.57
- Conditions
- Delirium, Cognitive Impairment, Cognitive Dysfunction, Cognitive Dysfunction, Postoperative, Delirium in Old Age, Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Jan 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.
There is lack of attention to preoperative cognitive function and delirium in elderly who underwent surgery. The investigators are investigating different tools that can help to screen for cognitive dysfunction and delirium in the future.
Detailed description
Background of the study:
The mean age of surgical patients is rising worldwide and this is associated with more multi-morbidity. Especially geriatric patients who undergo surgery have a higher risk to develop Postoperative Cognitive Dysfunction or a Postoperative Delirium, which leads to higher morbidity and mortality after surgery and this leads to higher healthcare costs.
A delirium is an acutely disturbed state of mind characterized by restlessness, illusions, and incoherence, occurring in intoxication, fever, and other disorders and can fluctuate over time. The hypoactive delirium, the most common type of delirium, is hard to recognize compared to the active delirium that is expressed by restlessness and agitation.
Postoperative cognitive dysfunction is defined as a new cognitive impairment arising after a surgical procedure. Its diagnosis requires both pre- and postoperative psychometric testing. Its manifestations are subtle and manifold, depending on the particular cognitive domains that are affected, and therefore hard to recognize too.
To assess preoperative cognitive function in large groups of patients, it's needed to have a simple and quick tool to screen. In this study, the investigators use the BAMCOG, which is a tool with 3 short games played on a tablet that can provide information about cognitive functioning. When writing this new study protocol, a validation study in which the BAMCOG is validated against the MoCA is running.
Beside the BAMCOG, another instrument will be investigated. The DeltaScan is an EEG delta waves measurement to identify patients with a (hypoactive) delirium. Delta waves are slow brainwaves that have been seen in sedated patients and even inpatients with an active or hypoactive delirium. A study of Kimchi et al. studied whether routine clinical EEG findings, including slowing, are correlated with delirium severity in a heterogeneous population with various causes of altered mental status and found that generalized slowing on routine clinical EEG strongly correlates with delirium and may be a valuable biomarker for delirium severity (OR 7.4, 95% CI 3.8-14.4).
A lot remains unclear about the biological mechanisms in the development of a delirium after surgery, although in literature are directions that inflammatory reactions and the neuro-endocrine system play an important role. That is the reason for investigating the relation between cortisol levels in blood, saliva and sweat and the development of postoperative acute encephalopathy.
Objective of the study:
- The predictive value of the BAMCOG for developing postoperative delirium/postoperative acute encephalopathy in patients who underwent AVR surgery
- Concurrent validation of the BAMCOG with the MoCA
- The relation between cortisol levels in blood, saliva and sweat and the development of postoperative delirium/postoperative acute encephalopathy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- 50 patients 65 years or older who will undergo AVR-bio surgery
Key inclusion criteria (4 listed)
- age >65 year
- scheduled for AVR surgery
- Able to play the BAMCOG games after instruction
- (Near) native (dutch)
Key exclusion criteria (12 listed)
- mental disorder
- learning disorder
- diagnosed dementia at start of study
- alcohol abuses
- lithium/clozapine use because of DeltaScan
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 |
|---|---|---|
| MoCAMoCA test to identify Mild Cognitive Impairment | Diagnostic test | – |
| BAMCOGThree games, compared to the MoCA to identify Mild Cognitive Impairment | Device | – |
| DeltaScanEEG to detect acute encephalopathy | Diagnostic test | – |
| SalivetteTo collect saliva for cortisol analysis | Diagnostic test | – |
| Pilocarpine iontophoresisTo collect sweat for cortisol analysis | Diagnostic test | – |
Primary outcome
Prognostic value of the preoperative BAMCOG to predict postoperative delirium
Time frame: BAMCOG and DeltaScan - preoperative 1 day, postoperative day 1, 3, 7.
2 secondary outcomes
Correlation BAMCOG scores and MoCA scores
Time frame: MoCA - preoperative 1 day, postoperative day 1, 3, 7
Prognostic value of cortisol measures (Sweat, Saliva, Serum) to predict postoperative delirium
Time frame: Preoperative at home and postoperative day 1
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 4 Apr 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cognitive Impairment, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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 4 inclusion and 12 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 4 Apr 2023. 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 Netherlands. 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?
Prognostic value of the preoperative BAMCOG to predict postoperative delirium (time frame: BAMCOG and DeltaScan - preoperative 1 day, postoperative day 1, 3, 7.). 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 4 Apr 2023.