ABCDEF Bundle to Prevent Delirium for COPD Patients

NCT ID: NCT06974318

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-08-31

Brief Summary

Abstract Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory disorder characterized by persistent airflow limitation and chronic respiratory symptoms, resulting from abnormalities in the bronchi, bronchioles, and alveoli. Patients with COPD may require admission to intensive care units (ICUs), particularly during acute exacerbations. In this context, both disease management and the prevention of potential complications, such as delirium, are of critical importance. Delirium is a common, preventable, and serious complication in ICUs that prolongs hospital stays, increases healthcare costs, and heightens the risk of infections. Hypoxia-induced cognitive impairment is among the key contributing factors to delirium in patients with COPD.

To improve patient outcomes, the ABCDEF Care Bundle was introduced in 2013 as a structured and evidence-based approach to ICU care. This study aims to evaluate the effectiveness of the ABCDEF Care Bundle in preventing delirium in patients with COPD admitted to the ICU. The research will be conducted as a randomized controlled trial between April and December 2025 in the third-level ICU of Taksim Training and Research Hospital. The study population will consist of COPD patients, with a total sample size of 84 patients (42 in each group), randomly assigned using a computer-assisted simple randomization method. A variety of validated instruments will be used to assess pain, sedation, cognitive status, mobility, and sleep quality.

The findings of this study are expected to contribute to the growing body of evidence supporting structured ICU care and to raise awareness among healthcare professionals regarding the implementation of the ABCDEF Care Bundle.

Keywords:

ABCDEF Care Bundle, Delirium, COPD, Intensive Care, Nursing Care, Randomized Controlled Trial

Conditions

Delirium; Copd; Nurse's Role

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control Group

This group will have "Standart Nursing Care" to prevent delirium.

Group Type: OTHER

Standard Care to Prevent Delirium

Intervention Type: OTHER

Standard care inclued pain management, Glasgow Coma Scale evaluation, Richmond Agitation-Sedation Scale evaluation and control of the stimulations.

Intervention Group

This group will have "ABCDEF Bundle" to prevent delirium.

Group Type: EXPERIMENTAL

ABCDEF Bundle to Prevent Delirium

Intervention Type: OTHER

The ABCDEF Care Bundle-comprising components focused on pain management (A), spontaneous awakening and breathing trials (B), choice of sedation and analgesia (C), delirium assessment and management (D), early mobility (E), and family engagement (F)-was developed to promote patient-centered care in the ICU and improve clinical outcomes. Nurses play a central role in the effective implementation of this bundle, given their continuous patient interaction and responsibility for early detection and response to delirium symptoms.

Interventions

ABCDEF Bundle to Prevent Delirium

The ABCDEF Care Bundle-comprising components focused on pain management (A), spontaneous awakening and breathing trials (B), choice of sedation and analgesia (C), delirium assessment and management (D), early mobility (E), and family engagement (F)-was developed to promote patient-centered care in the ICU and improve clinical outcomes. Nurses play a central role in the effective implementation of this bundle, given their continuous patient interaction and responsibility for early detection and response to delirium symptoms.

Intervention Type: OTHER

Standard Care to Prevent Delirium

Standard care inclued pain management, Glasgow Coma Scale evaluation, Richmond Agitation-Sedation Scale evaluation and control of the stimulations.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients aged 18 and over,
• No cognitive disease such as dementia or Alzheimer's,
• Patients requiring intensive care monitoring for at least 24 hours,
• Non-intubated patients,
• Having a diagnosis of COPD.

Exclusion Criteria

• Patients being monitored in intensive care primarily due to central nervous system disease,
• Intubated patients.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul Saglik Bilimleri University

OTHER

Sponsor Role: lead

Responsible Party

Emine Ezgi Ozcelik

Nurse, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IstanbulSBU-HSBE-EEO-01

Identifier Type: -

Identifier Source: org_study_id