Postoperative Cognitive DisorderNCT04943458
Application of Innovative Non-Invasive Neuroprotective Technology in Cardiac Surgery and Ophthalmology
An observational study of Postoperative Cognitive Disorder and Glaucoma, run by Milda Svagzdiene at 1 site in Lithuania.
Trial summary
Postoperative cognitive dysfunction (POCD) and delirium (incidence up to 42 %) after cardiac surgery with cardiopulmonary bypass (CPB) are common postoperative complications that impair the patient's quality of life and increase the risk of death. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Postoperative Cognitive Disorder, Glaucoma
- What is being tested?
- Monitoring of cerebral autoregulation
- How many people
- 270 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Sep 2021to 1 Oct 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include patients treated at the Clinic of Eye Diseases, Hospital of Lithuanian UHS and patients undergoing elective cardiac surgery (coronary artery bypass graft surgery) at the Clinic of Cardiovascular and Thoracic Surgery, Hospital of Lithuanian UHS.
Who may be able to join
- Criteria for the inclusion of the CA monitoring method in cardiac surgery:
- Age 18-90 years.
- The patient, after reading the personal information form, confirms in writing his / her consent to participate in the study.
- An AVJS operation is planned.
- No ophthalmological or neurological disorders have been identified prior to surgery.
- Criteria for the inclusion of the CA monitoring method in ophthalmology:
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- Age 18-90 years.
- The patient, after reading the personal information form, confirms in writing his / her consent to participate in the study.
- Patients with glaucoma changes in the optic disc and eye area shall be included in the study group.
- The control group shall include volunteers who are free from glaucoma, acute or chronic uncompensated disease that may affect the results of the studies, and age and anthropometric data from other study groups.
Who cannot join
- No written consent of a person to participate in a biomedical research has been obtained;
- Persons under 18 years of age.
- A woman who may become pregnant, be pregnant or breastfeeding.
- The patient is allergic or sensitive to local anesthetics.
- Patients with an eye disease that may distort the results of the test, if so decided by the researcher.
- The patient had an orbital or eye injury.
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- Has an acute or chronic but currently exacerbated respiratory disease.
- Patients with uncompensated cardiovascular diseases (II-III AV block or cardiogenic shock).
- Diabetes mellitus treated with more than one hypoglycaemic agent and / or insulin injections.
- Cognitive impairment diagnosed before surgery
- History of neurological diseases
- It is not possible to perform a qualitative neuropsychological examination due to other reasons (hearing, vision, etc. disorders)
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Milda Svagzdiene
Kaunas
Svagzdiene, +37061203924, milda.svagzdiene@lsmuni.lt
About this study
Postoperative cognitive dysfunction (POCD) and delirium (incidence up to 42 %) after cardiac surgery with cardiopulmonary bypass (CPB) are common postoperative complications that impair the patient's quality of life and increase the risk of death. Our previous studies confirm that postoperative POCD are associated with impaired cerebral autoregulation (CA) and momentary increased intracranial pressure (ICP) during surgery. The upper and lower limits of CA are individual and variable. In the elderly, CA is already partially impaired due to decreased cerebral vascular elasticity. What should be the optimal mean arterial pressure for each of these patients individually is not known. In order to individualize the boundaries of CA and prevent postoperative neurological complications, it would be ideal to objectify the condition of cerebral blood vessels. Direct studies of cerebrovascular and vascular status (CT angiography) are invasive and complex, and are therefore not routinely performed prior to cardiac surgery. However, cerebral blood flow and vascular condition can be assessed by retinal blood vessels, which can be considered as a direct biomarker of cerebrovascular disorders and can be visualized by ophthalmoscopy and objectively assessed by optical coherent tomography with angiography.
In this biomedical study, individual patient CA will be monitored in a non-invasive manner during cardiac surgery with CPB. These data would allow real-time adjustments to physiological parameters while keeping them within normal limits. This is expected to reduce the risk of CA impairment and reduce the incidence of neurological complications following such surgery.
Glaucoma is one of the leading causes of irreversible blindness in the world. As the population ages, the number of people with glaucoma increases as the prevalence of glaucoma increases with age. Recently, the influence of ICP on glaucoma optic neuropathy has been highlighted. It is thought that the pressure difference in the optic nerve area may be related to damage to the axons of the ganglion cells passing through the porous plate. Noninvasive ICP measurement is useful in explaining the pathophysiology of glaucoma, assessing translaminar pressure differentials, and seeking new guidelines for the treatment and prevention of glaucoma. Retinal blood flow, like cerebral blood flow, is autoregulated, autoregulation is maintained only within certain limits of perfusion pressure. Decreased ocular perfusion pressure impairs retinal autoregulation and may lead to the development or progression of glaucoma neuropathy. And the activity of neurons in the brain and retina causes local changes in blood circulation. Disruption of this neurovascular interaction during glaucoma neuropathy has not been adequately studied.The introduction of modern technologies into clinical practice enables the qualitative and quantitative assessment of autoregulatory disorders and the selection of optimal treatment.
- Conditions
- Postoperative Cognitive Disorder, Glaucoma
- Being tested
- Monitoring of cerebral autoregulation
- Medical subject headings
- Postoperative Cognitive Complications, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of cerebral autoregulationOther
Also called Non invasive ICP monitoring
Patients will be monitored for cerebral autoregulation using a Vittamed 505 monitor to identify the dynamics of the autoregulation index VRx (t). Intracranial pressure (ICP) will also be measured by non-invasive ultrasound using a robotic TCD device, Dolphin4D (Israel), which simultaneously records MCA blood flow in both hemispheres of the brain. APAs will be assessed using mathematical models.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery group | Not described Receives: Other: Monitoring of cerebral autoregulation | |
| Glaucoma group | Not described Receives: Other: Monitoring of cerebral autoregulation | |
| Control group | Not described Receives: Other: Monitoring of cerebral autoregulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impaired cerebral autoregulation and glaucoma neuropathy
Duration of the longest episode of CA disorder (threshold VRx> 0, threshold VRx> 0.2, threshold VRx> 0.4) showing impaired CA and the changes in vascular density ( %) of OCT-A macular temporal sector assessing the course of glaucoma neuropathy.
Measured: 1 days
Secondary outcomes (1)
POCD and glaucoma neuropathy
. Postoperative cognitive impairment. Changes in vascular density (%) of the lower temporal sector of the OCT-A optic nerve disc for monitoring structural changes in glaucoma neuropathy
Measured: 5 days up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Sep 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DisorderStudies 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
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milda Svagzdiene
- Sponsor type
- University, hospital or other
- Collaborators
- Kaunas University of Technology
- Responsible party
- Sponsor-investigator, Milda Svagzdiene, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943458
- Sponsor's protocol ID
- Nr.1
- Status last verified
- Apr 2022
- First submitted
- 21 Jun 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kasputyte G, Kumpaitiene B, Svagzdiene M, Andrejaitiene J, Sirvinskas E, Hamarat Y, Chaleckas E, Putnynaite V, Bartusis L, Zakelis R, Petkus V, Ragauskas A, Lenkutis T, Benetis R. Delirium after coronary artery bypass grafting with cardiopulmonary bypass surgery: The value of cerebral autoregulation. Perfusion. 2026 May;41(4):462-469. doi: 10.1177/02676591251370076. Epub 2025 Aug 17.
PubMed 40820307
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Innovative Non-Invasive Neuroprotective Technology in Cardiac Surgery and Ophthalmology
- ClinicalTrials.gov ID
- NCT04943458
- Acronym / sponsor ID
- Nr.1
- Conditions
- Postoperative Cognitive Disorder, Glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Milda SvagzdieneUniversity, hospital or other
- Collaborators
- Kaunas University of Technology
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 29 Jun 2021 (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.
Postoperative cognitive dysfunction (POCD) and delirium (incidence up to 42 %) after cardiac surgery with cardiopulmonary bypass (CPB) are common postoperative complications that impair the patient's quality of life and increase the risk of death. Our previous studies confirm that postoperative POCD are associated with impaired cerebral autoregulation (CA) and momentary increased intracranial pressure (ICP) during surgery. The upper and lower limits of CA are individual and variable. In the elderly, CA is already partially impaired due to decreased cerebral vascular elasticity. What should be the optimal mean arterial pressure for each of these patients individually is not known. In order to individualize the boundaries of CA and prevent postoperative neurological complications, it would be ideal to objectify the condition of cerebral blood vessels. Direct studies of cerebrovascular and vascular status (CT angiography) are invasive and complex, and are therefore not routinely performed prior to cardiac surgery. However, cerebral blood flow and vascular condition can be assessed by retinal blood vessels, which can be considered as a direct biomarker of cerebrovascular disorders and can be visualized by ophthalmoscopy and objectively assessed by optical coherent tomography with angiography.
In this biomedical study, individual patient CA will be monitored in a non-invasive manner during cardiac surgery with CPB. These data would allow real-time adjustments to physiological parameters while keeping them within normal limits. This is expected to reduce the risk of CA impairment and reduce the incidence of neurological complications following such surgery.
Glaucoma is one of the leading causes of irreversible blindness in the world. As the population ages, the number of people with glaucoma increases as the prevalence of glaucoma increases with age. Recently, the influence of ICP on glaucoma optic neuropathy has been highlighted. It is thought that the pressure difference in the optic nerve area may be related to damage to the axons of the ganglion cells passing through the porous plate. Noninvasive ICP measurement is useful in explaining the pathophysiology of glaucoma, assessing translaminar pressure differentials, and seeking new guidelines for the treatment and prevention of glaucoma. Retinal blood flow, like cerebral blood flow, is autoregulated, autoregulation is maintained only within certain limits of perfusion pressure. Decreased ocular perfusion pressure impairs retinal autoregulation and may lead to the development or progression of glaucoma neuropathy. And the activity of neurons in the brain and retina causes local changes in blood circulation. Disruption of this neurovascular interaction during glaucoma neuropathy has not been adequately studied.The introduction of modern technologies into clinical practice enables the qualitative and quantitative assessment of autoregulatory disorders and the selection of optimal treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery group | – | Other: Monitoring of cerebral autoregulation |
| Glaucoma group | – | Other: Monitoring of cerebral autoregulation |
| Control group | – | Other: Monitoring of cerebral autoregulation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include patients treated at the Clinic of Eye Diseases, Hospital of Lithuanian UHS and patients undergoing elective cardiac surgery (coronary artery bypass graft surgery) at the Clinic of Cardiovascular and Thoracic Surgery, Hospital of Lithuanian UHS.
Key inclusion criteria (10 listed)
- Criteria for the inclusion of the CA monitoring method in cardiac surgery:
- Age 18-90 years.
- The patient, after reading the personal information form, confirms in writing his / her consent to participate in the study.
- An AVJS operation is planned.
- No ophthalmological or neurological disorders have been identified prior to surgery.
Key exclusion criteria (12 listed)
- No written consent of a person to participate in a biomedical research has been obtained;
- Persons under 18 years of age.
- A woman who may become pregnant, be pregnant or breastfeeding.
- The patient is allergic or sensitive to local anesthetics.
- Patients with an eye disease that may distort the results of the test, if so decided by the researcher.
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 |
|---|---|---|
| Monitoring of cerebral autoregulationAlso: Non invasive ICP monitoringPatients will be monitored for cerebral autoregulation using a Vittamed 505 monitor to identify the dynamics of the autoregulation index VRx (t). Intracranial pressure (ICP) will also be measured by non-invasive ultrasound using a robotic TCD device, Dolphin4D (Israel), which simultaneously records MCA blood flow in both hemispheres of the brain. APAs will be assessed using mathematical models. | Other | Cardiac surgery group, Control group, Glaucoma group |
Primary outcome
Impaired cerebral autoregulation and glaucoma neuropathy
Time frame: 1 days
Duration of the longest episode of CA disorder (threshold VRx> 0, threshold VRx> 0.2, threshold VRx> 0.4) showing impaired CA and the changes in vascular density ( %) of OCT-A macular temporal sector assessing the course of glaucoma neuropathy.
1 secondary outcome
POCD and glaucoma neuropathy
Time frame: 5 days up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Derived from this study: PubMed 40820307Kasputyte G, Kumpaitiene B, Svagzdiene M, Andrejaitiene J, Sirvinskas E, Hamarat Y, Chaleckas E, Putnynaite V, Bartusis L, Zakelis R, Petkus V, Ragauskas A, Lenkutis T, Benetis R. Delirium after coronary artery bypass grafting with cardiopulmonary bypass surgery: The value of cerebral autoregulation. Perfusion. 2026 May;41(4):462-469. doi: 10.1177/02676591251370076. Epub 2025 Aug 17.
- 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.
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 Cognitive Disorder and Glaucoma, run by Milda Svagzdiene at 1 site in Lithuania.
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 10 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: status not confirmed, as of the sponsor's last update on 5 Apr 2022. 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 Lithuania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impaired cerebral autoregulation and glaucoma neuropathy (time frame: 1 days). 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 NCT04943458, which also lists 1 linked publication.
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 5 Apr 2022.