Clinical trial NCT05523258: The Effect and Mechanism of Computerized Cognition Training on the Incidence of Postoperative Cognitive Dysfunction After Cardiac Surgery
Official title: The Effect and Mechanism of Computerized Cognition Training on the Incidence of Postoperative Cognitive Dysfunction After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Cognitive Dysfunction(POCD)
Keywords: POCD
cardiac surgery
cognitive training
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 174
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Whether enough time and high-quality cognitive training will reduce the incidence of postoperative cognitive dysfunction after cardiac surgery.

Detailed description: Firstly, after patients are admitted, the researchers will visit every patient, introduce the study protocol, the risks and rights of the subjects to them in detail, and obtain their signed informed consent. Then, researches will collect the baseline data of the patients and complete the baseline status data measurement, including cognitive function, sleep quality, anxiety and depression scores, multi-channel EEG recorder monitoring and functional magnetic resonance examination.

According to the results of randomization, the intervention will be carried out according to the study protocol.

The day before the operation, EEG cortical network connection status, cognitive function, sleep quality, anxiety and depression scores will be measured after the intervention to understand the effect of preoperative intervention on brain function.

On the day of operation, anesthesia and operation will be performed according to clinical routine. And the multi-channel EEG will be detected after induction of anesthesia and during the period of sedation and recovery.When the patient meets the appropriate conditions, cognitive function training will be started as soon as possible.

Researches will evaluate the patients' sleep quality and the incidence of delirium in the first six days after the operation. They will also evaluate cognitive function, sleep quality, anxiety and depression scores, and conduct postoperative delirium evaluation, multi-channel EEG recorder monitoring, functional magnetic resonance examination on the seventh day after operation.The cognitive function, sleep quality, anxiety and depression scores will be measured 30 days after operation.

The Clinical Research Institute of Peking University undertakes the work of data collection and analysis of this project. A electronic data acquisition system based on network is used for data acquisition, where researchers need to input the research data accurately, timely and comprehensively. The audit and quality control will be fed back to the researchers in time. The researchers need to check the feedback one by one and record the check results in detail.

Eligibility criteria: Inclusion Criteria:

* Agree to participate in this study voluntarily;
* Age ≥ 60 years old；
* Patients who intend to accept elective coronary artery bypass grafting or valve replacement；
* The preoperative hospital stay is expected to be 5 days or more.

Exclusion Criteria:

* Definite diagnosis of senile dementia and Montreal Cognitive Assessment(MoCA) score ≤ 18;
* Patients with severe visual or hearing impairment who cannot complete the cognitive function assessment;
* Patients with limb movement disorder who cannot complete the cognitive function assessment;
* Patients with claustrophobia who cannot complete functional magnetic resonance imaging(fMRI) examination;
* The expected survival time is less than 1 month;
* Patients within 3 months or participating in other clinical trials.

Primary outcomes:
measure: Incidence of postoperative 7-day cognitive dysfunction
timeFrame: The 7th day after operation
Secondary outcomes:
measure: Postoperative 7-day changes of cognitive scores
timeFrame: The 7th day after operation
measure: Postoperative 7-day changes of cortical network connectivity function
timeFrame: The 7th day after operation
measure: Postoperative 7-day changes of sleep quality
timeFrame: The 7th day after operation
measure: Incidence of postoperative delirium within 7 days
timeFrame: Within 7 days after operation
measure: Incidence of postoperative 30-day cognitive dysfunction
timeFrame: The 30th day after operation
measure: Postoperative 30-day main complications and mortality
timeFrame: The 30th day after operation
Other outcomes:
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