Clinical Trial

The Trajectory and Influencing Factors of Cognitive Level in ICU Delirium Patients After Transfer Out of the ICU

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Record status
This record was last updated December 16, 2024 (before its estimated March 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
Introduction:Delirium is a prevalent psychiatric disorder observed in the Intensive Care unit(ICU) hat; often aggravates patients; overall health status, extends the duration of mechanical ventilation, prolongs ICU stays, and causes persistent or long-term cognitive impairment. A plethora of studies have indicated that the frequency, duration, and severity of delirium during hospitalization are significant risk factors for cognitive impairment in patients following transfer from the ICU. However, existing research has predominantly focused on cross-sectional analyses without delving into the influencing factors among patient subgroups. Consequently, the aim of this study is to employ the Latent Growth Curve Model (LGCM) and the Latent Class Growth Model (LCGM) model to analyze the trajectory of cognitive development and influencing factors of patients with delirium in the ICU one year after discharge. Methods and analysis:This prospective study aims to investigate the trajectory of cognitive level variations of patients with delirium in ICU for one year. It is planned to recruit 240 participants and gather comprehensive data including general demographics, disease-related information, scores from the Minimum Mental State Examination, Hospital Anxiety and Depression Scale, and the Pittsburgh Sleep Quality Index. All data will be followed up using the same schedule on the day of transfer, 1 month after transfer, 3 months after transfer, 6 months after transfer and 1 year after transfer. Ultimately, the investigators will employ Latent Growth Curve Model and Latent Class Growth Model to analyze the trajectory of cognitive changes and identify potential categories, in addition to utilizing logistic regression modeling to explore influencing factors. The results of this study provide a theoretical framework for the clinical implementation of precision nursing interventions within this demographic, so as to prevent and reduce the decline of cognitive function and improve the quality of life of patients.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-11-03; most recent amendment 2024-12-10.
Trial Details
NCT Number NCT06674603
Lead Sponsor Zunyi Medical College
Collaborators: Guizhou Nursing Vocational College
Conditions Cognition Disorder, ICU, Delirium
Enrollment 240 participants
Start Date 2024-09-30
Primary Completion 2026-03-30 (estimated)
Study Completion 2026-05-30 (estimated)
Updated on ClinicalTrials.gov 2024-12-16