Clinical Trial

PDCA-Based Precision Nursing for Stroke Patients With Tracheostomy

Study acronym: PDCA-ST
Completed
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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.
Trial Details
NCT Number NCT07687342
Lead Sponsor The First Affiliated Hospital of Soochow University
Conditions Stroke, Tracheostomy
Enrollment 80 participants
Start Date 2026-02-01
Primary Completion 2026-06-28 (estimated)
Study Completion 2026-06-28 (estimated)
Updated on ClinicalTrials.gov 2026-07-07