跳至主要内容
临床试验/NCT06279390
NCT06279390已完成不适用

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

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 381 人开始时间: 2023年6月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
381
试验地点
1
主要终点
the incidence of delirium

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

the incidence of delirium

时间窗: duration of ICU stay (postoperative 30 days)

The incidence of delirium which was assessed by each shift primary ICU nurse by using the ICDSC.

次要结局

  • day of physical restraint(duration of ICU stay (postoperative 30 days))
  • cumulative dose of sedatives(duration of ICU stay (postoperative 30 days))
  • level of mobility(duration of ICU stay (postoperative 30 days))
  • rate of unplanned self-extubation(duration of intubation( (postoperative 30 days))
  • duration of ventilator use(duration of ICU stay( (postoperative 30 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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