New trial tests faster way to remove tracheostomy tubes in Brain-Injured patients
NCT ID NCT07173634
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two methods—speaking valve trial and capping trial—to decide when it's safe to remove a tracheostomy tube in patients with prolonged disorders of consciousness. The speaking valve trial lasts 4 hours, while the capping trial takes 48 hours. Researchers will track how many patients successfully have their tubes removed and how long they stay in the hospital. The goal is to see if the speaking valve method is faster and more effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- speaking valve trial
- What this could lead to
- If successful, this could provide a faster and more reliable method to remove tracheostomy tubes in patients with prolonged disorders of consciousness, potentially reducing hospital stays.
- What could go wrong
- This is an early-stage study with no prior large-scale evidence. The results may not apply to all patients, and the speaking valve trial might not be better than the standard capping trial.
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
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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
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About 280 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Adults (18-80 years) with tracheostomy 2. Prolonged DoC (\>28 days) confirmed by CRS-R score \>0 3. Ventilator-free \>48h 4. PaCO₂ \<60 mmHg 5. PCF ≥100 L/min 6. No sepsis/organ failure 7. Controlled pulmonary infection 8. Written informed consent by legal representative Exclusion Criteria: 1. Intolerance to cuff deflation: 2. SpO₂ \<93% on O₂ supplementation OR Respiratory rate \>20/min for \>5min 3. Severe tracheal stenosis (\>50% lumen occlusion on CT) 4. Death within 2 weeks post-enrollment 5. Participation in conflicting interventional trial
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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
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Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China
Beijing, Beijing Municipality, 100043, China
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