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

Completed

• Conditions: Intensive Care Unit Delirium

• Registration Number: NCT06279390
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-06-08
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Study First Submitted: 2023-11-12
• Study First Submitted QC: 2024-02-25
• Last Update Submitted: 2024-02-25
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 381

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the incidence of delirium	duration of ICU stay (postoperative 30 days)	The incidence of delirium which was assessed by each shift primary ICU nurse by using the ICDSC.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan