NCT06279390

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

Completed Last updated 28 February 2024

What this trial tests

trial in Intensive Care Unit Delirium in 381 participants. Completed in 30 October 2023.

Timeline

8 June 2023

Primary endpoint
30 October 2023

30 October 2023

Quick facts

Lead sponsor	National Taiwan University Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	381
Start date	8 June 2023
Primary completion	30 October 2023
Estimated completion	30 October 2023
Sites	1 location across Taiwan

Conditions studied

• Intensive Care Unit Delirium — all drugs for Intensive Care Unit Delirium →

Sponsor

National Taiwan University Hospital

Who can join

Adults 18 to 99, any sex, with Intensive Care Unit Delirium. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.