Cardiovascular SurgeryNCT06692309
Exploring the Predictive Value of Electroencephalography Features in Perioperative Neurocognitive Disorders Following Cardiovascular Surgery
An observational study of Cardiovascular Surgery and Perioperative Neurocognitive Disorders, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
To explore the predictive value of Electroencephalography features in Perioperative Neurocognitive Disorders in patients undergoing cardiovascular surgery under general anesthesia Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Surgery, Perioperative Neurocognitive Disorders
- What is being tested?
- cardiovascular surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. older than 60 years 2. ASA grade: I-III 3. undergoing coronary artery bypass surgery or valve replacement surgery under general anaesthesia 4. able to complete cognitive function tests
Who may be able to join
- Written informed consent
- undergoing coronary artery bypass surgery or valve replacement surgery under general anaesthesia
- ASA grade: II-IV
- older than 60 years
- Able to complete cognitive function tests
Who cannot join
- history of severe neurological diseases and psychiatric diseases
- history of drug abuse
- severe hearing or vision impairment
- preoperative delirium
- serious adverse reactions such as cardiac arrest and cardiopulmonary resuscitation during surgery
- patients undergoing secondary surgery in a short period
- participation in concurrent clinical trials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, 100020
Changwei Wei, 13810678936 ext. +86, changwei.wei@ccmu.edu.cn
About this study
Official title: To Explore the Predictive Value of Electroencephalography Features in Perioperative Neurocognitive Disorders in Patients Undergoing Cardiovascular Surgery Under General Anaesthesia: a Single-centre Prospective Observational Study
To explore the predictive value of Electroencephalography features in Perioperative Neurocognitive Disorders in patients undergoing cardiovascular surgery under general anesthesia
Read the detailed description
Data was acquired on the ward using a 10-20 system with a standard 32-channel EEG cap and an EEG instrument (BP Company, Gilching, Germany). Patients were tested using cognitive assessment scales before and after surgery.
Cognitive levels were assessed 1 day before surgery and 1 week after surgery (7±2 days) using the Montreal Cognitive Assessment (MoCA) . Patients were followed up one month (30±2 days) after surgery using the Telephone version of the Montreal Cognitive Assessment Scale (T-MoCA).
Preoperative and postoperative electroencephalography brain network-related indexes (such as cluster coefficient, small world index, etc.) in patients with PND will be included in the analysis.
- Being tested
- cardiovascular surgery
- Keywords
- Perioperative Neurocognitive Disorders;Electroencephalography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiovascular surgeryProcedure or surgery
Heart bypass surgery; Heart valve replacement surgery
| Study group | Role | What they receive |
|---|---|---|
| Perioperative Neurocognitive Disorders | Postoperative delirium was assessed using the confusion assessment method or the confusion assessment method for the intensive care unit (CAM/CAM-ICU) .
Cognitive levels were assessed 1 day before surgery and 1 week after surgery (7±2 days) using the Montreal Cognitive Assessment (MoCA). Patients were followed up one month (30±2 days) after surgery using the Telephone version of the Montreal Cognitive Assessment Scale (T-MoCA). Receives: Procedure: cardiovascular surgery | |
| No-Perioperative Neurocognitive Disorders | Postoperative delirium was assessed using the confusion assessment method or the confusion assessment method for the intensive care unit (CAM/CAM-ICU) .
Cognitive levels were assessed 1 day before surgery and 1 week after surgery (7±2 days) using the Montreal Cognitive Assessment (MoCA). Patients were followed up one month (30±2 days) after surgery using the Telephone version of the Montreal Cognitive Assessment Scale (T-MoCA). Receives: Procedure: cardiovascular surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The predictive value of preoperative Electroencephalography features in patients with postoperative cognitive dysfunction following cardiovascular surgery
Data was acquired on the ward using a 10-20 system with a standard 32-channel EEG cap and an EEG instrument (BP Company, Gilching, Germany). Patients were tested using cognitive assessment scales before and after surgery.
Cognitive levels were assessed 1 day before surgery and 1 week after surgery (7±2 days) using The Montreal Cognitive Assessment (MoCA) . Patients were followed up one month (30±2 days) after surgery using the Telephone version of the Montreal Cognitive Assessment Scale (T-MoCA).
Measured: 2025.08
Secondary outcomes (2)
The predictive value of preoperative Electroencephalography features in patients with postoperative delirium following cardiovascular surgery
Postoperative delirium was assessed using the confusion assessment method or the confusion assessment method for the intensive care unit (CAM/CAM-ICU) .
Measured: 2025.08
Electroencephalography features in patients with postoperative delirium
Electroencephalography was collected in delirium patients one week(7±2 days) after surgery. Postoperative delirium was assessed using the confusion assessment method or the confusion assessment method for the intensive care unit (CAM/CAM-ICU) .
Preoperative and postoperative electroencephalography brain network-related indexes (such as cluster coefficient, small world index, etc.) in patients with postoperative delirium will be included in the analysis.
Measured: 2025.08
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Mar 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular SurgeryStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anshi Wu, doctor, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692309
- Sponsor's protocol ID
- DXK2022-ke-487
- Status last verified
- May 2025
- First submitted
- 22 May 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Predictive Value of Electroencephalography Features in Perioperative Neurocognitive Disorders in Patients Undergoing Cardiovascular Surgery Under General Anaesthesia: a Single-centre Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06692309
- Acronym / sponsor ID
- DXK2022-ke-487
- Keywords
- Perioperative Neurocognitive Disorders;Electroencephalography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 18 Nov 2024 (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.
To explore the predictive value of Electroencephalography features in Perioperative Neurocognitive Disorders in patients undergoing cardiovascular surgery under general anesthesia
Detailed description
Data was acquired on the ward using a 10-20 system with a standard 32-channel EEG cap and an EEG instrument (BP Company, Gilching, Germany). Patients were tested using cognitive assessment scales before and after surgery.
Cognitive levels were assessed 1 day before surgery and 1 week after surgery (7±2 days) using the Montreal Cognitive Assessment (MoCA) . Patients were followed up one month (30±2 days) after surgery using the Telephone version of the Montreal Cognitive Assessment Scale (T-MoCA).
Preoperative and postoperative electroencephalography brain network-related indexes (such as cluster coefficient, small world index, etc.) in patients with PND will be included in the analysis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perioperative Neurocognitive Disorders | – | Procedure: cardiovascular surgeryPostoperative delirium was assessed using the confusion assessment method or the confusion assessment method for the intensive care unit (CAM/CAM-ICU) . Cognitive levels were assessed 1 day before surgery and 1 week after surgery (7±2 days) using the Montreal Cognitive Assessment (MoCA). Patients were followed up one month (30±2 days) after surgery using the Telephone version of the Montreal Cognitive Assessment Scale (T-MoCA). |
| No-Perioperative Neurocognitive Disorders | – | Procedure: cardiovascular surgeryPostoperative delirium was assessed using the confusion assessment method or the confusion assessment method for the intensive care unit (CAM/CAM-ICU) . Cognitive levels were assessed 1 day before surgery and 1 week after surgery (7±2 days) using the Montreal Cognitive Assessment (MoCA). Patients were followed up one month (30±2 days) after surgery using the Telephone version of the Montreal Cognitive Assessment Scale (T-MoCA). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. older than 60 years 2. ASA grade: I-III 3. undergoing coronary artery bypass surgery or valve replacement surgery under general anaesthesia 4. able to complete cognitive function tests
Key inclusion criteria (5 listed)
- Written informed consent
- undergoing coronary artery bypass surgery or valve replacement surgery under general anaesthesia
- ASA grade: II-IV
- older than 60 years
- Able to complete cognitive function tests
Key exclusion criteria (7 listed)
- history of severe neurological diseases and psychiatric diseases
- history of drug abuse
- severe hearing or vision impairment
- preoperative delirium
- serious adverse reactions such as cardiac arrest and cardiopulmonary resuscitation during surgery
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 |
|---|---|---|
| cardiovascular surgeryHeart bypass surgery; Heart valve replacement surgery | Procedure or surgery | No-Perioperative Neurocognitive Disorders, Perioperative Neurocognitive Disorders |
Primary outcome
The predictive value of preoperative Electroencephalography features in patients with postoperative cognitive dysfunction following cardiovascular surgery
Time frame: 2025.08
Data was acquired on the ward using a 10-20 system with a standard 32-channel EEG cap and an EEG instrument (BP Company, Gilching, Germany). Patients were tested using cognitive assessment scales before and after surgery. Cognitive levels were assessed 1 day before surgery and 1 week after surgery (7±2 days) using The Montreal Cognitive Assessment (MoCA) . Patients were followed up one month (30±2 days) after surgery using the Telephone version of the Montreal Cognitive Assessment Scale (T-MoCA).
2 secondary outcomes
The predictive value of preoperative Electroencephalography features in patients with postoperative delirium following cardiovascular surgery
Time frame: 2025.08
Electroencephalography features in patients with postoperative delirium
Time frame: 2025.08
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Anshi Wu, doctor principal investigator
Beijing Chao Yang Hospital
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 Cardiovascular Surgery and Perioperative Neurocognitive Disorders, run by Beijing Chao Yang Hospital at 1 site in China.
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 5 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: looking for participants now, as of the sponsor's last update on 30 May 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Changwei Wei, doctor (13810678936 ext. +86, changwei.wei@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The predictive value of preoperative Electroencephalography features in patients with postoperative cognitive dysfunction following cardiovascular surgery (time frame: 2025.08). 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 30 May 2025.