PDCA-Based Precision Nursing for Stroke Patients With Tracheostomy (PDCA-ST)

Effect of a PDCA Cycle-Based Precision Nursing Program on Clinical Outcomes in Stroke Patients With Tracheostomy: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Tracheostomy
• Intervention / Treatment: Behavioral: PDCA Cycle-Based Precision Nursing Program; Other: Routine Nursing Care

Detailed Description

Background: Stroke is a leading cause of disability and mortality worldwide. Many patients with severe stroke require tracheostomy to maintain airway patency and facilitate respiratory management. However, tracheostomy bypasses the physiological functions of the upper airway, increasing the risks of pulmonary infection, secretion retention, and airway-related complications. Although routine airway nursing is commonly implemented, evidence supporting a structured quality improvement model for tracheostomy care remains limited.

Objective: The primary objective is to determine whether a PDCA cycle-based precision nursing program reduces the incidence of pulmonary infection compared with routine nursing care in stroke patients with tracheostomy.

Secondary objectives are to evaluate the effects of the intervention on sputum viscosity, arterial blood gas parameters (PaO₂, PaCO₂, and oxygenation index), nursing satisfaction, and the occurrence of adverse events including unplanned extubation, incision infection, and airway mucosal injury.

Study Design: This is a prospective, single-center, randomized, single-blind, parallel-group controlled trial. Eighty participants meeting the eligibility criteria will be randomly allocated in a 1:1 ratio to either the intervention group or the control group using a computer-generated randomization sequence with sealed opaque envelopes. Outcome assessors and statisticians will remain blinded to treatment allocation.

Intervention: Participants in the control group will receive routine nursing care, including standard airway management, oxygen therapy, suctioning, nebulization, nutritional support, and routine tracheostomy care.

Participants in the intervention group will receive routine nursing plus a structured PDCA cycle-based precision nursing program. The intervention consists of multidisciplinary quality management following the Plan-Do-Check-Act framework together with seven standardized nursing modules, including catheter safety management, continuous airway humidification, graded secretion management, standardized incision care, individualized airway clearance, aspiration prevention, and early rehabilitation training.

Outcome Measures: The primary outcome is the incidence of pulmonary infection during hospitalization. Secondary outcomes include sputum viscosity, arterial blood gas parameters (PaO₂, PaCO₂, oxygenation index), nursing satisfaction, and safety outcomes including unplanned extubation, incision infection, and airway mucosal injury.

Study Duration: Participant recruitment is planned from March 2025 through March 2026. Participants will receive the assigned intervention from enrollment until hospital discharge or transfer. No post-discharge follow-up is planned.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PDCA-Based Precision Nursing Group; 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; 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.; Other: 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.
Active Comparator: Routine Nursing Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sputum Viscosity	Sputum viscosity will be assessed using the three-grade sputum viscosity classification (Grade I, II, and III) before intervention and at hospital discharge or transfer.	Baseline and hospital discharge or transfer, up to approximately 5 months
Partial Pressure of Oxygen	Partial pressure of oxygen (PaO2) will be measured using arterial blood gas analysis before intervention and at hospital discharge or transfer.	Baseline and hospital discharge or transfer, up to approximately 5 months
Partial Pressure of Carbon Dioxide	Partial pressure of carbon dioxide (PaCO2) will be measured using arterial blood gas analysis before intervention and at hospital discharge or transfer.	Baseline and hospital discharge or transfer, up to approximately 5 months
Oxygenation Index	The oxygenation index will be calculated based on arterial blood gas analysis before intervention and at hospital discharge or transfer.	Baseline and hospital discharge or transfer, up to approximately 5 months
Nursing Satisfaction	Nursing satisfaction will be evaluated using a validated nursing satisfaction questionnaire completed by patients' family members within 24 hours before hospital discharge or transfer.	Within 24 hours before hospital discharge or transfer, up to approximately 5 months
Adverse Events	Safety outcomes include the incidence of unplanned extubation, tracheostomy incision infection, and airway mucosal injury occurring during the study period.	From enrollment until hospital discharge or transfer, up to approximately 5 months

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Actual): June 28, 2026
• Study Completion (Actual): June 28, 2026

Study Registration Dates

• First Submitted: June 28, 2026
• First Submitted That Met QC Criteria: July 4, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 4, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Randomized Controlled Trial; Airway Management; Tracheostomy; Quality Improvement; Pulmonary Infection; Nursing Intervention; Respiratory Care; Precision Nursing; PDCA Cycle
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: FAHSU-PDCA-STROKE-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because of participant privacy protection, institutional data management requirements, and the absence of prior consent for public data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No