PDCA-Based Precision Nursing for Stroke Patients With Tracheostomy

NCT07687342 | Completed

• 1 other identifier: FAHSU-PDCA-STROKE-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Tracheostomy

Keywords

PDCA Cycle; Precision Nursing; Stroke; Tracheostomy; Pulmonary Infection; Airway Management; Randomized Controlled Trial; Nursing Intervention; Quality Improvement; Respiratory Care

Outcome Measures

Primary Outcomes (1)

• Incidence of Pulmonary Infection

  Pulmonary infection will be diagnosed by an independent physician who is blinded to treatment allocation according to the 2018 Chinese Guidelines for the Diagnosis and Treatment of Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia. The incidence of pulmonary infection will be compared between the two study groups.

  From enrollment until hospital discharge or transfer, up to approximately 5 months

Secondary Outcomes (6)

• Sputum Viscosity

  Baseline and hospital discharge or transfer, up to approximately 5 months

• Partial Pressure of Oxygen

  Baseline and hospital discharge or transfer, up to approximately 5 months

• Partial Pressure of Carbon Dioxide

  Baseline and hospital discharge or transfer, up to approximately 5 months

• Oxygenation Index

  Baseline and hospital discharge or transfer, up to approximately 5 months

• Nursing Satisfaction

  Within 24 hours before hospital discharge or transfer, up to approximately 5 months

Study Arms (2)

PDCA-Based Precision Nursing Group

EXPERIMENTAL

Participants in this group will receive routine nursing care plus a PDCA cycle-based precision nursing program from enrollment until hospital discharge or transfer. The intervention includes catheter safety management, continuous airway humidification, graded secretion management, standardized incision care, individualized airway clearance, aspiration prevention, and early rehabilitation training.

Behavioral: PDCA Cycle-Based Precision Nursing Program; Other: Routine Nursing Care

Routine Nursing Group

ACTIVE COMPARATOR

Participants in this group will receive routine nursing care, including standard airway management, oxygen therapy, suctioning, nebulization, nutritional support, and routine tracheostomy wound care from enrollment until hospital discharge or transfer.

Other: Routine Nursing Care

Interventions

Routine Nursing Care OTHER

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.

PDCA-Based Precision Nursing Group; Routine Nursing Group

PDCA Cycle-Based Precision Nursing Program BEHAVIORAL

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.

PDCA-Based Precision Nursing Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-blind study. Participants and care providers are aware of treatment allocation because of the nature of the nursing intervention. Outcome assessors and statisticians remain blinded to group assignment throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the PDCA cycle-based precision nursing group or the routine nursing group. Both groups will receive their assigned intervention throughout hospitalization, and outcomes will be compared between the two parallel groups.

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 7, 2026
• Study Start: February 1, 2026
• Primary Completion: June 28, 2026
• Study Completion: June 28, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)