Skip to main content
OpenTrials
Completed

NCT Number: NCT07054268

Nurse-Led Implementation of the ABCDEF Bundle

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helwan University

Helwan, Cairo Governorate, 11731, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Nurse-Led ABCDEF Bundle Implementation

Other

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.

Primary outcomes

  1. Incidence of ICU Delirium

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 8, 2025
Registry last updated
Jul 8, 2025

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.

Published trials that share one or more normalized conditions with this study.