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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06279390
Enrollment
381
Registered
2024-02-28
Start date
2023-06-08
Completion date
2023-10-30
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit Delirium

Brief 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.

Interventions

None listed

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years

Inclusion criteria

1\. SICU patients are over 18 years old. 2. received surgery intervention

Exclusion criteria

1. Clinical diagnosis of mental disorders 2. Underwent neurosurgical procedures, 3. Discharged from the ICU within 24 hours of admission 4. Transitioned to active life support withdrawal or comfort care only within 24 hours of ICU admission

Design outcomes

Primary

MeasureTime frameDescription
the incidence of deliriumduration of ICU stay (postoperative 30 days)The incidence of delirium which was assessed by each shift primary ICU nurse by using the ICDSC.

Secondary

MeasureTime frameDescription
cumulative dose of sedativesduration of ICU stay (postoperative 30 days)Sedatives cumulative drugs include midazolam, propofol and dexmedetomidine record 24hours
duration of ventilator useduration of ICU stay( (postoperative 30 days)duration of ventilator use
rate of unplanned self-extubationduration of intubation( (postoperative 30 days)indicates the proportion of patients who unintentionally remove their endotracheal tubes (Yes/No)
day of physical restraintduration of ICU stay (postoperative 30 days)day of physical restraint
level of mobilityduration of ICU stay (postoperative 30 days)level 0-10 of mobility

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026