PDCA-Based Precision Nursing for Stroke Patients With Tracheostomy

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.

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.

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.