- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06423547
Risk Warning Model of Postoperative Delirium and Long-term Cognitive Dysfunction in Elderly Patients
March 30, 2025 updated by: Xuanwu Hospital, Beijing
Risk Warning Model of Postoperative Delirium and Long-term Cognitive Dysfunction in Elderly Patients Based on Autonomous Evolutionary Neural Network Algorithm
The incidence of postoperative delirium in elderly patients is high, which can lead to long-term postoperative neurocognitive disorders.
Its high risk factors are not yet clear.
At present, there is a lack of early diagnosis and alarm technology for perioperative neurocognitive disorders, which can not achieve early intervention and effective treatment.
By artificial intelligence and autonomously evolutionary neural network algorithm, relying on multi-source clinical big data, we explored the use of Bayesian network to optimize the anesthesia decision-making system in enhanced recovery after surgery, and established risk prediction model for perioperative critical events.
It is expected that this method will also help to establish a risk prediction model for postoperative delirium and long-term postoperative neurocognitive disorders.
This project plans to collect the perioperative sensitive parameters of anesthesia machine, multi-parameter monitor, EEG monitor,fMRI and HIS system, to explore the evolution process of data characteristics by feature fusion.We also plan to quickly screen key perioperative risk characteristics of postoperative delirium from massive clinical data through feature selection, to explore the high risk factors of long-term postoperative neurocognitive disorders developing from postoperative delirium.
Finally, with multi-center intelligent analysis,the risk prediction model of postoperative delirium and long-term postoperative neurocognitive disorders will be constructed.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
This project intends to collect and identify clinical monitoring data of anesthesia machine, multi-parameter monitor and brain function monitor on the basis of the team's previous series of studies on cognitive function protection of elderly patients in perioperative period and the research on tracking and warning of critical illness events and decision support services based on artificial intelligence.
HIS clinical data and classified and tracked fMRI imaging data were integrated to form a large data set related to perioperative cognitive function of elderly patients.
Based on pNCD clinical diagnostic information and fMRI imaging diagnostic information, a brain adverse event prediction system capable of intelligent extraction of clinical key information and real-time early warning was established by using key technologies such as data quality control, real-time collection and identification of multi-source clinical monitoring data, and artificial intelligence adverse event prediction.
Study Type
Observational
Enrollment (Estimated)
10000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: lei zhao
- Phone Number: +8613811035886
- Email: zhaoalei@sina.com
Study Contact Backup
- Name: xia li li
- Phone Number: +86818810616341
- Email: 935496838@qq.com
Study Locations
-
-
-
Beijing, China, 100053
- Recruiting
- Xuanwu Hospital, Capital Medical University
-
Contact:
- Lei Zhao, Doctor's
- Phone Number: +8613811035886
- Email: zhaoalei@sina.com
-
Contact:
- Lixia Li, Master's
- Phone Number: +86818810616341
- Email: 935496838@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients 65~100 years of age who have undergone surgical anesthesia
Description
Inclusion Criteria:
- Patients ≥65 years of age who have undergone surgical anesthesia; Sign informed consent
Exclusion Criteria:
- Inability to complete cognitive function assessment; Illiteracy, hearing impairment or visual impairment; He has a history of epilepsy, depression, schizophrenia, Alzheimer's disease and other psychiatric and neurological diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
postoperative delirium(POD) and postoperative neurocognitive disorder(pNCD)
Delirium (CAM scale ) was assessed 7 days after surgery and divided into POD and non-POD groups; one of the above scenarios indicated postoperative delirium;The patients in the POD group were evaluated for cognitive function at 1 month and 12 months after surgery to determine whether pNCD occurred.
The patients in the POD group were further divided into pNCD subgroup and non-PNCD subgroup, and EEG data collection and fMRI scanning were performed
|
this is an observation study,no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Screening for risk factors of perioperative cognitive dysfunction
Time Frame: 2024.4.1-2027.12.31
|
The feature selection technique in artificial intelligence was used to screen and analyze data from a large dataset of clinical care after fusion The risk factors with the highest probability of PND occurrence can be screened from a large number of characteristics,By screening the risk factors that have the highest correlation with the probability of POD occurrence, combined with the comparison of fMRI imaging data of different groups of large sample size POD patients with long-term conversion to pNCD group and non-PNCD group, the brain network mechanism and perioperative high risk factors of POD conversion to long-term cognitive dysfunction were further explored.
|
2024.4.1-2027.12.31
|
|
Establish a prediction system for adverse brain function events
Time Frame: 2025.1.1-2027.12.31
|
The monitoring data of surgical patients contains a large amount of medical information, and the analysis and modeling of the data can provide effective early warning and intervention.
The project intends to adopt EEG time-frequency feature extraction and analysis, EEG micro-state analysis, and brain network analysis, and adopt feature fusion technology to fuse various features into unified features of patients.
On this basis, a prediction model of adverse brain function events based on domain adaptation algorithm was constructed to realize real-time tracking, early diagnosis and early warning of postoperative delirium and long-term cognitive dysfunction in elderly patients
|
2025.1.1-2027.12.31
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: lei zhao, xuanwu hospital of capital medical university,Beijing
- Principal Investigator: yong yang, Chongqing Institute of Green and Intelligent Technology, Chinese Academy of Sciences
- Principal Investigator: yi an, xuanwu hospital of capital medical university,Beijing
- Principal Investigator: xia li li, xuanwu hospital of capital medical university,Beijing
- Principal Investigator: yang liu, xuanwu hospital of capital medical university,Beijing
- Principal Investigator: yi shu yang, xuanwu hospital of capital medical university,Beijing
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Patel A, Zhang M, Liao G, Karkache W, Montroy J, Fergusson DA, Khadaroo RG, Tran DTT, McIsaac DI, Lalu MM. A Systematic Review and Meta-analysis Examining the Impact of Age on Perioperative Inflammatory Biomarkers. Anesth Analg. 2022 Apr 1;134(4):751-764. doi: 10.1213/ANE.0000000000005832.
- An Y, Zhao L, Wang T, Huang J, Xiao W, Wang P, Li L, Li Z, Chen X. Preemptive oxycodone is superior to equal dose of sufentanil to reduce visceral pain and inflammatory markers after surgery: a randomized controlled trail. BMC Anesthesiol. 2019 Jun 11;19(1):96. doi: 10.1186/s12871-019-0775-x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 30, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
May 15, 2024
First Submitted That Met QC Criteria
May 15, 2024
First Posted (Actual)
May 21, 2024
Study Record Updates
Last Update Posted (Actual)
April 3, 2025
Last Update Submitted That Met QC Criteria
March 30, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 62376168
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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