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Cough test could help thousands breathe without a tracheostomy tube

NCT ID NCT07317791

Knowledge-focused 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 trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 aims to confirm that measuring cough flow through a tracheostomy tube with a speaking valve can safely predict when the tube can be removed. Researchers will enroll 500 adults who have had a tracheostomy for at least 14 days and are breathing on their own. If successful, this simple test could replace riskier methods and improve decannulation success rates.

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 500 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Sep 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 90 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 ≥18 years * Tracheostomy tube in place for ≥14 days * Weaned from ventilator for more than 48 hours, or in a state of spontaneous breathing * Patient and family members have provided informed consent Exclusion Criteria: * Severe craniofacial deformity preventing CFsv measurement * Known obstructive upper airway pathology precluding tracheostomy tube removal * Laryngopharyngeal trauma * Inability to tolerate cuff deflation

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As listed by the trial registrant

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

Tracheostomy

How to take part

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

  1. The places running it

    5 sites. 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, Beijing,China

    Beijing, Beijing Municipality, 100043, China

  • Hunan Rehabilitation Hospital

    Hunan, Hunan, 410000, China

  • Jiangbin Hospital of Guangxi Zhuang Autonomous Region

    Guangxi, Jiangbin, 530012, China

  • YanBian University Hospital

    Jilin City, Yanbian, 133000, China

  • Zhengzhou Central Hospital Affiliated to Zhengzhou University

    Henan, Zhengzhou, 450007, China

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