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NCT Number: NCT06279390

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Clinical diagnosis of mental disorders
  • Underwent neurosurgical procedures,
  • Discharged from the ICU within 24 hours of admission
  • Transitioned to active life support withdrawal or "comfort care only" within 24 hours of ICU admission

Treatment and study plan

Primary outcomes

  1. the incidence of delirium

    Time frame: 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 outcomes

  1. duration of ventilator use

    Time frame: duration of ICU stay( (postoperative 30 days)

    duration of ventilator use

  2. rate of unplanned self-extubation

    Time frame: duration of intubation( (postoperative 30 days)

    indicates the proportion of patients who unintentionally remove their endotracheal tubes (Yes/No)

  3. day of physical restraint

    Time frame: duration of ICU stay (postoperative 30 days)

    day of physical restraint

  4. level of mobility

    Time frame: duration of ICU stay (postoperative 30 days)

    level 0-10 of mobility

  5. cumulative dose of sedatives

    Time frame: duration of ICU stay (postoperative 30 days)

    Sedatives cumulative drugs include midazolam, propofol and dexmedetomidine record 24hours

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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