StrokePDCA-STNCT07687342
PDCA-Based Precision Nursing for Stroke Patients With Tracheostomy
A study testing PDCA Cycle-Based Precision Nursing Program and Routine Nursing Care in people with Stroke and Tracheostomy, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke, Tracheostomy
- What is being tested?
- PDCA Cycle-Based Precision Nursing Program and Routine Nursing Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 28 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Tracheostomy
- Being tested
- PDCA Cycle-Based Precision Nursing Program, Routine Nursing Care
- Keywords
- PDCA Cycle, Precision Nursing, Stroke, Tracheostomy, Pulmonary Infection, Airway Management, Randomized Controlled Trial, Nursing Intervention, Quality Improvement, Respiratory Care
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDCA Cycle-Based Precision Nursing ProgramBehavioural
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.
Routine Nursing CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine Nursing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment until hospital discharge or transfer, up to approximately 5 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment until hospital discharge or transfer, up to approximately 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Feb 2026
- Primary completion28 Jun 2026
- Study completion28 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AnQi Ba, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687342
- Sponsor's protocol ID
- FAHSU-PDCA-STROKE-01
- Acronym
- PDCA-ST
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a PDCA Cycle-Based Precision Nursing Program on Clinical Outcomes in Stroke Patients With Tracheostomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07687342
- Acronym / sponsor ID
- PDCA-ST / FAHSU-PDCA-STROKE-01
- Conditions
- Stroke, Tracheostomy
- Keywords
- PDCA Cycle, Precision Nursing, Stroke, Tracheostomy, Pulmonary Infection, Airway Management, Randomized Controlled Trial, Nursing Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 28 Jun 2026 (actual)
- Study completion
- 28 Jun 2026 (actual)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PDCA-Based Precision Nursing Group | Experimental | Behavioral: PDCA Cycle-Based Precision Nursing Program, Other: Routine Nursing CareParticipants 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. |
| Routine Nursing Group | Active comparator | Other: Routine Nursing CareParticipants 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. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDCA Cycle-Based Precision Nursing ProgramThe 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. | Behavioural | PDCA-Based Precision Nursing Group |
| Routine Nursing CareRoutine 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. | Other | PDCA-Based Precision Nursing Group, Routine Nursing Group |
Primary outcome
Incidence of Pulmonary Infection
Time frame: From enrollment until hospital discharge or transfer, up to approximately 5 months
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.
6 secondary outcomes
Sputum Viscosity
Time frame: Baseline and hospital discharge or transfer, up to approximately 5 months
Partial Pressure of Oxygen
Time frame: Baseline and hospital discharge or transfer, up to approximately 5 months
Partial Pressure of Carbon Dioxide
Time frame: Baseline and hospital discharge or transfer, up to approximately 5 months
Oxygenation Index
Time frame: Baseline and hospital discharge or transfer, up to approximately 5 months
Nursing Satisfaction
Time frame: Within 24 hours before hospital discharge or transfer, up to approximately 5 months
Adverse Events
Time frame: From enrollment until hospital discharge or transfer, up to approximately 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDCA Cycle-Based Precision Nursing Program and Routine Nursing Care in people with Stroke and Tracheostomy, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Pulmonary Infection (time frame: From enrollment until hospital discharge or transfer, up to approximately 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 28 Oct 2026.