## Protocol Section
### Identification Module
**NCT ID:** NCT06427265

**Brief Title:** 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

**Official Title:** 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

#### Organization Study ID Info
**ID:** ZHKYQ202316
#### Organization
**Class:** OTHER
**Full Name:** The Affiliated Hospital Of Guizhou Medical University
### Status Module
#### Completion Date
**Date:** 2026-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-19

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Chinese nursing association

**Class:** UNKNOWN

**Name:** Affiliated Hospital of Guizhou Medical University

#### Lead Sponsor

**Class:** OTHER

**Name:** The Affiliated Hospital Of Guizhou Medical University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Developmental Trajectory of Patients With Post-ICU Syndrome

- Development and Application of Post-ICU Syndrome Prediction Model

**Keywords:**

- Post-icu syndrome

- Prediction model

- Development Trajectory

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 840

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Intensive Care Unit Memory Tool score\\Richards-Campbell Sleep Questionnaire score

**Measure:** Correlation scale score

**Time Frame:** 2024.01-2026.06

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Length of stay in ICU ≥24h; ②Age ≥18 years old; ③ Conscious when leaving ICU, communicating with investigators without barriers; ④ Informed consent.

Exclusion Criteria:

* ① had been admitted to ICU for more than 24h within 3 months prior to this admission; ② Transferred to another ICU; ③ There was cognitive impairment before ICU admission (BDRS \> 4); (4) Serious hearing impairment, dysarthria, etc., can not be followed up; ⑤ Serious illness can not cooperate to complete the questionnaire.

**Healthy Volunteers:** True

**Maximum Age:** 100 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** The inclusion criteria of family members were as follows: 1 family member of each patient aged ≥18 years was selected; (2) Assume the main role of caring for patients and medical decision-making; ③ no history of mental illness or other serious organic diseases; ④ Informed consent, voluntary participation in this study. Exclusion criteria for family members: ① Family members refused to participate in the study due to their own reasons; ② Severe hearing and language impairment could not cooperate with the researchers.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** W19117899885@163.com

**Name:** Tingrui WANG

**Phone:** 19117899885

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** GuiYang

**Contacts:**

***Contact 1:***

- **Email:** W19117899885@163.com

- **Name:** Tingrui WANG

- **Phone:** 19117899885

- **Role:** CONTACT

**Country:** China

**Facility:** Affiliated Hospital of Guizhou Medical University

**State:** Guizhou

**Status:** RECRUITING

**Zip:** 550004

#### Overall Officials

**Official 1:**

**Affiliation:** Affiliated Hospital of Guizhou Medical University

**Name:** Li Yao

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M19010

- Name: Critical Illness

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

### Condition Browse Module - Meshes

- ID: D000013577

- Term: Syndrome

### Misc Info Module

- Version Holder: 2024-05-31
