Clinical trial NCT06974318: ABCDEF Bundle to Prevent Delirium for COPD Patients
Official title: The Evaluation of the Effect of ABCDEF Bundle Implementation on Preventing Delirium in Patients Followed in the Medical Intensive Care Patients Due to Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Delirium
Copd
Nurse's Role
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A-Two Arms Randomized Controlled Trial
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: The research has not started yet. Instutional (hospital) permission is being awaited.
timeFrame: 12 months
measure: Power Analysis
timeFrame: 12 months
measure: Forms- Informed Consent Form
timeFrame: 12 months
measure: Forms- Patient Information Form (1)
timeFrame: 12 months
measure: Forms- Patient Information Form (2)
timeFrame: 12 months
measure: Forms- Chronic Obstructive Pulmonary Disease (COPD) Assessment Questionnaire
timeFrame: 12 months
measure: Forms- Numeric Pain Rating Scale and Facial Pain Rating Scale
timeFrame: 12 months
measure: Forms- Glasgow Coma Scale
timeFrame: 12 months
measure: Forms- Richmond Agitation-Sedation Scale
timeFrame: 12 months
measure: Forms- Nursing Delirium Screening Tool
timeFrame: 12 months
measure: Forms- Intensive Care Delirium Screening List
timeFrame: 12 months
measure: Forms- Richards-Campbell Sleep Questionnaire
timeFrame: 12 months
measure: Forms- Intensive Care Unit Mobilization Scale
timeFrame: 12 months
measure: Forms- ABCDEF Bundle Action Plan Form
timeFrame: 12 months
measure: Forms: ABCDEF Bundle Action Plan Form Explanation (1)
timeFrame: 12 months
measure: Forms: ABCDEF Bundle Action Plan Form Explanation (2)
timeFrame: 12 months
measure: Forms- ABCDEF Bundle Checklist
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
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