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

Intensive Care Unit Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06279390
• Other study ID #: 202305126RINC
• Status: Completed
• Start date: June 8, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: June 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Intensive Care Unit Delirium

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of delirium	The incidence of delirium which was assessed by each shift primary ICU nurse by using the ICDSC.	duration of ICU stay (postoperative 30 days)
Secondary	duration of ventilator use	duration of ventilator use	duration of ICU stay( (postoperative 30 days)
Secondary	rate of unplanned self-extubation	indicates the proportion of patients who unintentionally remove their endotracheal tubes (Yes/No)	duration of intubation( (postoperative 30 days)
Secondary	day of physical restraint	day of physical restraint	duration of ICU stay (postoperative 30 days)
Secondary	level of mobility	level 0-10 of mobility	duration of ICU stay (postoperative 30 days)
Secondary	cumulative dose of sedatives	Sedatives cumulative drugs include midazolam, propofol and dexmedetomidine record 24hours	duration of ICU stay (postoperative 30 days)