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New valve trial could help stroke patients breathe easier and speak sooner

NCT ID NCT07435727

Symptom relief Sponsor: Hongying Jiang, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests two ways to help stroke patients safely remove their breathing tubes (tracheostomy). One method uses a speaking valve that allows talking, while the other gradually caps the tube. Researchers will compare success rates and safety in 120 patients across multiple hospitals.

What this could mean

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

Active substance
Passy-Muir Speaking Valve and tracheostomy tube capping
What this could lead to
If successful, this could provide a safer, more comfortable way to remove breathing tubes in stroke patients, potentially speeding recovery and reducing complications.
What could go wrong
This is a relatively small, early-stage study. The results may not apply to all stroke patients, and the interventions themselves carry risks like breathing difficulty or infection.

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

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

18 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: Stroke (ischemic or hemorrhagic) with subsequent tracheostomy. Stable stage of stroke: clinically in the post-acute or sequelae stage, with stable vital signs, resolved cerebral edema, normalized intracranial pressure, no new neurological deficits. Clinically stable, defined as: ventilator-free for ≥48 hours prior to enrollment; stable vital signs (temperature \<38°C, heart rate 60-100 bpm, respiratory rate \<20/min, systolic blood pressure 90-160 mmHg); no active severe infection requiring IV antibiotics; no organ failure; partial pressure of Carbon Dioxide(PaCO₂) \<60 mmHg. Peak Cough Flow (PCF) ≥100 L/min. 24-hour subglottic secretion volume \<20 ml. Signed informed consent by patient or legal representative. Exclusion Criteria: Intolerance to cuff deflation: severe cough, dyspnea, SpO₂ \<93% (on supplemental oxygen), or respiratory rate \>20/min for \>5 minutes. Severe airway structural abnormalities: tracheal stenosis (\>50% lumen occlusion confirmed by Computed Tomography or bronchoscopy), tracheoesophageal fistula. Life expectancy \<2 weeks or planned transfer to a non-participating institution within 2 weeks. Severe uncontrolled neurological or systemic diseases (e.g., advanced cancer, severe heart failure).

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Rehabilitation Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100043, China

More trials for these conditions

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