Machine Learning-based Longitudinal Study of Post-ICU Syndrome Development Trajectory in Critically Ill Patients and Construction of Clinical Early Warning Models: a Research Protocol for Longitudinal Study

NCT ID: NCT06427265

Last Updated: 2025-05-31

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

840 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-06-01

Brief Summary

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This project intends to track and evaluate whether post-ICU syndrome will occur 7 days, 1 month, 3 months and 6 months after ICU patients are transferred out of the ICU through a longitudinal study, apply the latent category growth model to identify different trajectory patterns of post-ICU syndrome in critically ill patients, and use modern machine learning models to build an early warning model of the trajectory patterns of post-ICU syndrome.

Detailed Description

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Conditions

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Intensive Care Unit Syndrome Prediction Cognitive Impairment Sleep Disorder Memory Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Length of stay in ICU ≥24h;
* Age ≥18 years old;
* Conscious when leaving ICU, communicating with investigators without barriers;
* Informed consent. Family members:
* One family member ≥18 years of age was selected for each patient;
* Assume the main role of caring for patients and medical decision-making;
* No history of mental illness or other serious organic diseases;
* Informed consent and voluntary participation in this study.

Exclusion Criteria

* Have been in ICU for more than 24h within 3 months before this admission;
* Transferred to another ICU;
* Cognitive impairment existed before ICU admission (BDRS \> 4 points);
* Severe hearing impairment, dysarthria, etc., which cannot be followed up;
* Unable to complete the questionnaire survey due to serious illness.

Family members:

* Family members refuse to participate in the study due to their own reasons;
* Severe hearing and language impairment, unable to cooperate with researchers.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese nursing association

UNKNOWN

Sponsor Role collaborator

The Affiliated Hospital Of Guizhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Yao

Role: STUDY_CHAIR

Affiliated Hospital of Guizhou Medical University

Locations

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Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tingrui WANG

Role: CONTACT

19117899885

Facility Contacts

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Tingrui WANG

Role: primary

19117899885

Other Identifiers

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No. ZHKYQ202316

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

No. Gyfynsfc[2023]35

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ZHKYQ202316

Identifier Type: -

Identifier Source: org_study_id

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