ABCDEF Bundle to Prevent Delirium for COPD Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstanbul Saglik Bilimleri University
About this trial
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
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
Patients being monitored in intensive care primarily due to central nervous system disease,
Intubated patients.
Trial design
Design model
Crossover
Treatments tested in this trial
ABCDEF Bundle to Prevent Delirium
Other interventionThe 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.
Standard Care to Prevent Delirium
Other interventionStandard care inclued pain management, Glasgow Coma Scale evaluation, Richmond Agitation-Sedation Scale evaluation and control of the stimulations.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Control GroupOther 1 intervention
Group B: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The research has not started yet. Instutional (hospital) permission is being awaited.
After obtaining the necessary permissions, data will be collected with forms. Data will be analyzed in the SPSS 29.0 program. Thirteen forms will be used to collect data: * Informed Consent Form * Patient Information Form * Numeric Pain Rating Scale * Facial Pain Rating Scale * Glasgow Coma Scale * Richmond Agitation-Sedation Scale * Chronic Obstructive Pulmonary Diseases (COPD) Assessment Questionnaire * Nursing Delirium Screening Scale * Intensive Care Delirium Control Screening List * Richards-Campbell Sleep Questionnaire * Intensive Care Unit Mobilization Scale ABCDEF Bundle Action Plan Form ABCDEF Bundle Checklist Note: ABCDEF Bundle is included in the literature with this name. This is not an abbreviation. ABCDEF Bundle: A: Assess the pain B: Both control spontaneous breathing and awakeaning C: Choice of sedation D: Delirium assesment E: Early mobilization F: Family encouragement and empowerment ABCDEF Bundle is working with "all or nothing" rule, so there is no minimum-maximum value.
Time frame
12 months2
Power Analysis
The aim of this study was to determine the effectiveness of the ABCDEF care bundle in preventing the development of delirium in COPD patients.The universe of the study will consist of patients who are being followed up with a diagnosis of COPD in the Intensive Care Unit of a Training and Research Hospital. There will be two groups in the study and the differences between the groups will be examined. In line with this study, when the effect level is determined as 0.8 and the power of the test is determined as 0.95, the number of samples that should be reached with a 5% error rate is calculated with the G\*Power 3.1.9.4 program, and it has been concluded that a minimum of 42 patients for each group and a total of 84 patients will be included in the study.
Time frame
12 months3
Forms- Informed Consent Form
-Informed Consent Form The research will be explained verbally to the volunteers participating in the study and both verbal and written consent will be obtained.
Time frame
12 months4
Forms- Patient Information Form (1)
-Patient Information Form Patients demographic essentials: Gender, age, weight, height (weight and height will be combined to report BMI kg/m²) Marital status: Single, married, divorced, in relationship, unmarried. Education situation: Gratuation of elementery school, high school, collage. Work situation: worker, white collar, retired, unemployee. Economic situation: income less than/equal to/more than expenses, These questions aim to detect patients worries (economic, work, family), and make nurses alert to their delirium predispositions.
Time frame
12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: