Risk Warning Model of Postoperative Delirium and Long-term Cognitive Dysfunction in Elderly Patients

NCT ID: NCT06423547

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-30

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Delirium Postoperative Neurocognitive Disorder Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

no intervention

Intervention Type OTHER

this is an observation study,no intervention

Interventions

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no intervention

this is an observation study,no intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chongqing Institute of Green and Intelligent Technology, Chinese Academy of Sciences

UNKNOWN

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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lei zhao

Role: STUDY_CHAIR

xuanwu hospital of capital medical university,Beijing

yong yang

Role: PRINCIPAL_INVESTIGATOR

Chongqing Institute of Green and Intelligent Technology, Chinese Academy of Sciences

yi an

Role: PRINCIPAL_INVESTIGATOR

xuanwu hospital of capital medical university,Beijing

xia li li

Role: PRINCIPAL_INVESTIGATOR

xuanwu hospital of capital medical university,Beijing

yang liu

Role: PRINCIPAL_INVESTIGATOR

xuanwu hospital of capital medical university,Beijing

yi shu yang

Role: PRINCIPAL_INVESTIGATOR

xuanwu hospital of capital medical university,Beijing

Locations

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Xuanwu Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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lei zhao

Role: CONTACT

+8613811035886

xia li li

Role: CONTACT

+86818810616341

Facility Contacts

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Lei Zhao, Doctor's

Role: primary

+8613811035886

Lixia Li, Master's

Role: backup

+86818810616341

References

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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.

Reference Type BACKGROUND
PMID: 34962902 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31185942 (View on PubMed)

Other Identifiers

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62376168

Identifier Type: -

Identifier Source: org_study_id

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