PDCA-Based Precision Nursing for Stroke Patients With Tracheostomy (PDCA-ST)
Effect of a PDCA Cycle-Based Precision Nursing Program on Clinical Outcomes in Stroke Patients With Tracheostomy: A Randomized Controlled Trial
Stroke patients undergoing tracheostomy are at high risk of pulmonary complications because tracheostomy bypasses the normal upper airway defense mechanisms and increases the risk of airway colonization and infection. Although routine nursing care is widely used, a standardized quality improvement strategy for airway management remains lacking.
This single-center, prospective, randomized, single-blind controlled trial aims to evaluate whether a PDCA (Plan-Do-Check-Act) cycle-based precision nursing program improves clinical outcomes in stroke patients with tracheostomy compared with routine nursing care. Eighty eligible participants will be randomly assigned in a 1:1 ratio to receive either the PDCA-based precision nursing intervention or routine nursing. The primary outcome is the incidence of pulmonary infection. Secondary outcomes include sputum viscosity, arterial blood gas parameters (PaO₂, PaCO₂, and oxygenation index), nursing satisfaction, and safety outcomes including unplanned extubation, incision infection, and airway mucosal injury.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Background: Stroke is a leading cause of disability and mortality worldwide. Many patients with severe stroke require tracheostomy to maintain airway patency and facilitate respiratory management. However, tracheostomy bypasses the physiological functions of the upper airway, increasing the risks of pulmonary infection, secretion retention, and airway-related complications. Although routine airway nursing is commonly implemented, evidence supporting a structured quality improvement model for tracheostomy care remains limited.
Objective: The primary objective is to determine whether a PDCA cycle-based precision nursing program reduces the incidence of pulmonary infection compared with routine nursing care in stroke patients with tracheostomy.
Secondary objectives are to evaluate the effects of the intervention on sputum viscosity, arterial blood gas parameters (PaO₂, PaCO₂, and oxygenation index), nursing satisfaction, and the occurrence of adverse events including unplanned extubation, incision infection, and airway mucosal injury.
Study Design: This is a prospective, single-center, randomized, single-blind, parallel-group controlled trial. Eighty participants meeting the eligibility criteria will be randomly allocated in a 1:1 ratio to either the intervention group or the control group using a computer-generated randomization sequence with sealed opaque envelopes. Outcome assessors and statisticians will remain blinded to treatment allocation.
Intervention: Participants in the control group will receive routine nursing care, including standard airway management, oxygen therapy, suctioning, nebulization, nutritional support, and routine tracheostomy care.
Participants in the intervention group will receive routine nursing plus a structured PDCA cycle-based precision nursing program. The intervention consists of multidisciplinary quality management following the Plan-Do-Check-Act framework together with seven standardized nursing modules, including catheter safety management, continuous airway humidification, graded secretion management, standardized incision care, individualized airway clearance, aspiration prevention, and early rehabilitation training.
Outcome Measures: The primary outcome is the incidence of pulmonary infection during hospitalization. Secondary outcomes include sputum viscosity, arterial blood gas parameters (PaO₂, PaCO₂, oxygenation index), nursing satisfaction, and safety outcomes including unplanned extubation, incision infection, and airway mucosal injury.
Study Duration: Participant recruitment is planned from March 2025 through March 2026. Participants will receive the assigned intervention from enrollment until hospital discharge or transfer. No post-discharge follow-up is planned.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Jiangsu
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Suzhou, Jiangsu, Китай, 215006
- The First Affiliated Hospital of Soochow University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Age 30 to 80 years.
- Diagnosis of first-ever stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) according to the Chinese Classification of Cerebrovascular Diseases (2015).
- Underwent tracheostomy following stroke.
- Not receiving mechanical ventilation or vasoactive drugs at enrollment.
- No evidence of pulmonary infection at enrollment.
- APACHE II score ≤20.
- No severe dysfunction of major organs.
- Written informed consent provided by the patient's legally authorized representative.
Exclusion Criteria:
- Pulmonary infection before enrollment.
- Severe respiratory failure, circulatory failure, or other severe organ failure.
- Contraindications to rehabilitation because of neurological, musculoskeletal, or orthopedic disorders.
- Hematologic diseases or severe coagulation disorders.
- Inability to complete the study protocol or incomplete clinical data.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: PDCA-Based Precision Nursing Group
Participants in this group will receive routine nursing care plus a PDCA cycle-based precision nursing program from enrollment until hospital discharge or transfer.
The intervention includes catheter safety management, continuous airway humidification, graded secretion management, standardized incision care, individualized airway clearance, aspiration prevention, and early rehabilitation training.
|
The PDCA cycle-based precision nursing program is a structured nursing intervention delivered in addition to routine nursing care.
It follows the Plan-Do-Check-Act quality improvement framework and includes catheter safety management, continuous airway humidification, graded secretion management, standardized incision care, individualized airway clearance, aspiration prevention, and early rehabilitation training.
The intervention is implemented from enrollment until hospital discharge or transfer.
Routine nursing care includes standard airway management, oxygen therapy, suctioning, nebulization, nutritional support, and routine tracheostomy wound care according to usual clinical practice.
It does not include the structured PDCA cycle-based precision nursing program.
|
|
Активный компаратор: Routine Nursing Group
Participants in this group will receive routine nursing care, including standard airway management, oxygen therapy, suctioning, nebulization, nutritional support, and routine tracheostomy wound care from enrollment until hospital discharge or transfer.
|
Routine nursing care includes standard airway management, oxygen therapy, suctioning, nebulization, nutritional support, and routine tracheostomy wound care according to usual clinical practice.
It does not include the structured PDCA cycle-based precision nursing program.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Incidence of Pulmonary Infection
Временное ограничение: From enrollment until hospital discharge or transfer, up to approximately 5 months
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Pulmonary infection will be diagnosed by an independent physician who is blinded to treatment allocation according to the 2018 Chinese Guidelines for the Diagnosis and Treatment of Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia.
The incidence of pulmonary infection will be compared between the two study groups.
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From enrollment until hospital discharge or transfer, up to approximately 5 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Sputum Viscosity
Временное ограничение: Baseline and hospital discharge or transfer, up to approximately 5 months
|
Sputum viscosity will be assessed using the three-grade sputum viscosity classification (Grade I, II, and III) before intervention and at hospital discharge or transfer.
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Baseline and hospital discharge or transfer, up to approximately 5 months
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Partial Pressure of Oxygen
Временное ограничение: Baseline and hospital discharge or transfer, up to approximately 5 months
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Partial pressure of oxygen (PaO2) will be measured using arterial blood gas analysis before intervention and at hospital discharge or transfer.
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Baseline and hospital discharge or transfer, up to approximately 5 months
|
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Partial Pressure of Carbon Dioxide
Временное ограничение: Baseline and hospital discharge or transfer, up to approximately 5 months
|
Partial pressure of carbon dioxide (PaCO2) will be measured using arterial blood gas analysis before intervention and at hospital discharge or transfer.
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Baseline and hospital discharge or transfer, up to approximately 5 months
|
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Oxygenation Index
Временное ограничение: Baseline and hospital discharge or transfer, up to approximately 5 months
|
The oxygenation index will be calculated based on arterial blood gas analysis before intervention and at hospital discharge or transfer.
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Baseline and hospital discharge or transfer, up to approximately 5 months
|
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Nursing Satisfaction
Временное ограничение: Within 24 hours before hospital discharge or transfer, up to approximately 5 months
|
Nursing satisfaction will be evaluated using a validated nursing satisfaction questionnaire completed by patients' family members within 24 hours before hospital discharge or transfer.
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Within 24 hours before hospital discharge or transfer, up to approximately 5 months
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Adverse Events
Временное ограничение: From enrollment until hospital discharge or transfer, up to approximately 5 months
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Safety outcomes include the incidence of unplanned extubation, tracheostomy incision infection, and airway mucosal injury occurring during the study period.
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From enrollment until hospital discharge or transfer, up to approximately 5 months
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- FAHSU-PDCA-STROKE-01
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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