Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-04 @ 11:45 AM
Study NCT ID:
NCT07054268
Status:
COMPLETED
Last Update Posted:
2025-07-08
First Post:
2025-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nurse-Led Implementation of the ABCDEF Bundle
Sponsor:
Helwan University
Organization:
Study Overview
Official Title:
Nurse-Led Implementation of the ABCDEF Bundle: Evidence-Based Strategies for ICU Delirium Management
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: