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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Jiangsu
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Suzhou、Jiangsu、中国、215006
- The First Affiliated Hospital of Soochow University
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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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.
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有源比较器：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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of Pulmonary Infection
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sputum Viscosity
大体时间：Baseline and hospital discharge or transfer, up to approximately 5 months
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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
大体时间：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
大体时间：Baseline and hospital discharge or transfer, up to approximately 5 months
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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
大体时间：Baseline and hospital discharge or transfer, up to approximately 5 months
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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
大体时间：Within 24 hours before hospital discharge or transfer, up to approximately 5 months
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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
大体时间：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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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- FAHSU-PDCA-STROKE-01
计划个人参与者数据 (IPD)
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IPD 计划说明
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