Clinical Trials Directory

Trials / Completed

CompletedNCT06279390

PRE-DELIRIC Prediction Model Plus SMART Care to Reduce the Incidence of Delirium in ICU Patients

Effectiveness of PRE-DELIRIC-Guided SMART/SmART Care in Reducing Delirium Incidence Among Surgical Intensive Care Unit Patients

Status
Completed
Phase
Study type
Observational
Enrollment
381 (actual)
Sponsor
National Taiwan University Hospital · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers

Summary

Delirium is a severe acute brain dysfunction characterised by sudden confusion, inattention and fluctuating level of consciousness, which mainly affects intubated intensive care patients. It increases the risk of self-extubation, prolongs ICU stay and increases mortality. The incidence of delirium in ICUs varies, with approximately 33.3% of patients affected, and rates of new-onset and pre-existing delirium range from 4% to 89%. Accurate diagnosis is challenging, with 60-80% of patients remaining undiagnosed. Early detection is critical for intervention and improved outcomes. To address these issues, the PREdiction of DELIRium (PRE-DELIRIC) model incorporates 10 risk factors and predicts delirium within 24 hours of ICU admission, allowing risk stratification into low to very high risk categories. It recalibrates predictive values with a sensitivity of 91.3% and specificity of 64.4% using a cut-off score of 27%. However, its integration into delirium management is underexplored. Delirium risk stratification supports efficient resource allocation, cost control, workload reduction and ethical care, while promptly identifying high-risk patients. In this study, Investigators evaluate the integration of the PRE-DELIRIC model into a comprehensive delirium management approach called PRE-DELIRIC-guided SMART/SmART care. SMART care includes improving familiarity, assessing pain and anxiety, reducing equipment discomfort and cognitive stimulation. Patients with PRE-DELIRIC scores \>30% receive SMART care and multidisciplinary involvement, based on the American Delirium Society.

Conditions

Timeline

Start date
2023-06-08
Primary completion
2023-10-30
Completion
2023-10-30
First posted
2024-02-28
Last updated
2024-02-28

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT06279390. Inclusion in this directory is not an endorsement.