NCT06974318Not yet recruiting
ABCDEF Bundle to Prevent Delirium for COPD Patients
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
Source: ClinicalTrials.gov · Last updated 15 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 22 Apr 2025
- Start date
- May 2025
- Primary completion date
- Jun 2026
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Diseases
- COPD
- NCT number
- NCT06974318
What you commit to
- Study type: Interventional
- Planned participants: 84
- From May 2025 to the primary completion date, Jun 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients being monitored in intensive care primarily due to central nervous system disease,
Other
- Intubated patients.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.