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Structured nursing plan aims to cut pneumonia in stroke patients with breathing tubes

NCT ID NCT07687342

Disease control Sponsor: The First Affiliated Hospital of Soochow University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study tests whether a structured nursing program, based on the Plan-Do-Check-Act quality improvement cycle, can reduce lung infections in stroke patients who have a tracheostomy (a breathing tube in the neck). The program includes careful airway care, suctioning, and early rehabilitation. Eighty participants will be randomly assigned to receive either this enhanced nursing or standard care, and the main outcome measured is the rate of pulmonary infection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PDCA Cycle-Based Precision Nursing Program
What this could lead to
If successful, this nursing approach could become a standard method to lower pneumonia rates and improve recovery in stroke patients with a tracheostomy.
What could go wrong
This is a small, single-center trial, so results may not apply broadly. The intervention is behavioral, not a drug, so benefits may be modest and hard to replicate.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

80 people

The number who actually took part.

Started

Feb 2026

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stroke Tracheostomy

Contacts and locations

Locations

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

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