NCT07054268

Nurse-Led Implementation of the ABCDEF Bundle

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Helwan University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Data were collected prospectively from patient medical records, bedside observations, and standardized assessment tools. Daily monitoring was conducted to ensure fidelity to the intervention and accurate documentation of outcomes. Ethical approval was obtained from the institutional review board. Written informed consent was obtained from patients or their legal representatives where applicable.

Conditions

• Delirium in the Intensive Care Unit

Interventions

Type	Name	Description
OTHER	Nurse-Led ABCDEF Bundle Implementation	This intervention is distinguished by its structured, nurse-led delivery of all six components of the ABCDEF bundle, with nurses serving as primary implementers rather than multidisciplinary teams. Unlike other studies that may focus on select elements of the bundle or physician-led application, this study emphasizes standardized nursing protocols and daily documentation to ensure consistent implementation and evaluation across all components specifically targeting delirium prevention and management in ICU patients.

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2025-07-08
• Last updated: 2025-07-08

Locations

1 site across 1 country: Egypt