Clinical trial NCT06427265: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intensive Care Unit Syndrome
Prediction
Cognitive Impairment
Sleep Disorder
Memory Disorders
Keywords: Post-icu syndrome
Prediction model
Development Trajectory
Lead sponsor: The Affiliated Hospital Of Guizhou Medical University
Sponsor class: OTHER
Collaborators: name: Chinese nursing association
First posted: 2024-05-23
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stage one involved studying patients discharged from the ICU and their families to investigate the occurrence and factors influencing post-intensive care syndrome (PICS), identifying various developmental patterns of PICS. A minimum sample size of 840 patients and 420 family members was established. Stage two focused on developing and evaluating a machine learning-based early warning model for PICS. The model construction utilized data from stage one, while the evaluation included 525 patients and 393 family members who met the exclusion criteria.

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.


Eligibility criteria: Inclusion Criteria patients :

* 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 patients :

* 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.

Primary outcomes:
measure: Correlation scale score
timeFrame: 2024-2026
Secondary outcomes:
Other outcomes:
Locations:
city: GuiYang
country: China
facility: Affiliated Hospital of Guizhou Medical University
state: Guizhou
Study officials:
affiliation: Affiliated Hospital of Guizhou Medical University
name: Li Yao
role: STUDY_CHAIR
References: