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Completed NCT07687342

PDCA-Based Precision Nursing for Stroke Patients With Tracheostomy

Conditions: Stroke, Tracheostomy

Sex: All
Ages: 30 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: The First Affiliated Hospital of Soochow University

Location: The First Affiliated Hospital of Soochow University Suzhou Jiangsu

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07687342). StuddyBuddy aggregates publicly available trial information.