NCT07687342Completed
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
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 28 Jun 2026
- Start date
- Feb 2026
- Primary completion date
- Jun 2026
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Stroke
- NCT number
- NCT07687342
What you commit to
- Study type: Interventional
- Participants enrolled: 80
- From Feb 2026 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Inability to complete the study protocol or incomplete clinical data.
Who the study is looking for
- 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.
Age in the registry: 30 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.