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临床试验/NCT07054268
NCT07054268已完成不适用

Nurse-Led Implementation of the ABCDEF Bundle: Evidence-Based Strategies for ICU Delirium Management

Helwan University2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年3月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
2
主要终点
Incidence of ICU Delirium

研究概览

简要总结

This study evaluated the effectiveness of a nurse-led implementation of the ABCDEF bundle, an evidence-based, interprofessional care framework, in the prevention and management of delirium among Intensive Care Unit (ICU) patients. The intervention aimed to reduce the incidence and severity of ICU delirium, decrease agitation, and improve patient outcomes through structured nursing interventions guided by the ABCDEF approach.

详细描述

The study employed a single-center, quasi-experimental clinical design with two parallel groups: an intervention group that received the nurse-led ABCDEF bundle and a control group that received standard ICU care. No randomization was applied, but baseline characteristics were matched where possible to control for confounding variables.

The study was conducted in the adult ICU of a tertiary care hospital. Eligible participants included adult patients (≥18 years) who were admitted to the ICU with an expected stay of at least 48 hours. Patients with pre-existing cognitive impairment, severe neurological damage, or those in a persistent vegetative state were excluded.

The intervention group received structured nursing care guided by the ABCDEF bundle, delivered by trained ICU nurses. The protocol included routine pain assessments and management strategies; daily spontaneous awakening and breathing trials; evidence-based sedation choices minimizing benzodiazepine use; systematic delirium screening using a validated tool (e.g., ICDSC); early mobilization practices appropriate to the patient's clinical status; and inclusion of family members in care planning and education.

The control group received usual ICU care without the formal implementation of the ABCDEF bundle.

The primary outcome was the incidence of delirium during the ICU stay, measured using a validated tool (e.g., ICDSC or CAM-ICU). Secondary outcomes included agitation levels, duration of delirium episodes, ICU length of stay, adherence to individual ABCDEF components, use of physical restraints, and sedative/analgesic dosages.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Critically ill adult patients aged 18 years or older
  • Admitted to the ICU at Ain Shams University Hospitals within 48 hours of enrollment
  • Clinically stable to undergo assessment and nursing intervention
  • Able to provide informed consent personally or via a legally authorized representative
  • Both male and female patients included

排除标准

  • Documented cognitive impairment or pre-existing psychiatric illness
  • Severe neurological conditions (e.g., advanced stroke, traumatic brain injury)
  • Deep sedation level (Richmond Agitation-Sedation Scale [RASS] score < -4)
  • Terminal illness requiring palliative or end-of-life care
  • Patients who declined participation or did not meet eligibility screening

结局指标

主要结局

Incidence of ICU Delirium

时间窗: From ICU admission to ICU discharge or up to 7 days, whichever occurs first

The presence or absence of delirium will be assessed daily using the Intensive Care Delirium Screening Checklist (ICDSC), a validated tool. Delirium is defined as an ICDSC score ≥4. The outcome will measure the proportion of patients who develop delirium during their ICU stay.

Incidence of ICU Delirium

时间窗: From ICU admission to ICU discharge or up to 7 days, whichever occurs first

The presence or absence of delirium will be assessed daily using the Intensive Care Delirium Screening Checklist (ICDSC), a validated tool. Delirium is defined as an ICDSC score ≥4. The outcome will measure the proportion of patients who develop delirium during their ICU stay.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Eldin Moustafa Hamed

Lecturer of Psychiatric and mental health Nursing

Helwan University

研究点 (2)

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