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PDCA-Based Precision Nursing for Stroke Patients With Tracheostomy
Sponsor: The First Affiliated Hospital of Soochow University
Summary
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.
Official title: Effect of a PDCA Cycle-Based Precision Nursing Program on Clinical Outcomes in Stroke Patients With Tracheostomy: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
30 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-02-01
Completion Date
2026-06-28
Last Updated
2026-07-07
Healthy Volunteers
No
Conditions
Interventions
PDCA Cycle-Based Precision Nursing Program
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
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.
Locations (1)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China