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Набор скоро начнётся NCT06974318

ABCDEF Bundle to Prevent Delirium for COPD Patients

Без фазы С лечением Delirium Copd Nurse's Role

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ABCDEF Bundle to Prevent Delirium, Standard Care to Prevent Delirium.
Кому может быть актуально
Состояния в реестре: Delirium, Copd, Nurse's Role. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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

Вмешательства

  • Другое 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
  • Другое Standard Care to Prevent Delirium
    Standard care inclued pain management, Glasgow Coma Scale evaluation, Richmond Agitation-Sedation Scale evaluation and control of the stimulations.

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06974318 · IstanbulSBU-HSBE-EEO-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗