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Not yet recruiting NCT06974318

ABCDEF Bundle to Prevent Delirium for COPD Patients

No phase Interventional Delirium Copd Nurse's Role

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ABCDEF Bundle to Prevent Delirium, Standard Care to Prevent Delirium.
Who it may be relevant to
Registry conditions: Delirium, Copd, Nurse's Role. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

Interventions

  • Other 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 r
  • 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.

Primary outcome measures

  • The research has not started yet. Instutional (hospital) permission is being awaited. [Time frame: 12 months]
  • Power Analysis [Time frame: 12 months]
  • Forms- Informed Consent Form [Time frame: 12 months]
  • Forms- Patient Information Form (1) [Time frame: 12 months]
  • Forms- Patient Information Form (2) [Time frame: 12 months]
  • Forms- Chronic Obstructive Pulmonary Disease (COPD) Assessment Questionnaire [Time frame: 12 months]
  • Forms- Numeric Pain Rating Scale and Facial Pain Rating Scale [Time frame: 12 months]
  • Forms- Glasgow Coma Scale [Time frame: 12 months]
  • Forms- Richmond Agitation-Sedation Scale [Time frame: 12 months]
  • Forms- Nursing Delirium Screening Tool [Time frame: 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06974318 · IstanbulSBU-HSBE-EEO-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗