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New procedure aims to help Brain-Injury patients breathe on their own

NCT ID NCT03512054

Disease control Sponsor: University Hospital, Bordeaux 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
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 Results may not be published yet.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)
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This status has not been confirmed recently, so it may be out of date.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 pilot study tested a standardized 5-step weaning procedure to safely remove tracheostomy tubes in 30 brain-injury patients. The procedure involves steps like deflating the tube cuff and using a speaking valve, with a team of doctors and nurses monitoring stability. The goal was to see if patients could be decannulated without needing the tube reinserted within 96 hours, potentially reducing hospital stays and improving recovery.

What this could mean

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

Active substance
Standardized 5-step weaning procedure
What this could lead to
If successful, this procedure could help brain-injury patients safely remove their tracheostomy tubes, potentially shortening hospital stays and easing the transition to rehabilitation.
What could go wrong
This is a small pilot study with only 30 participants, so results may not apply to all patients. The procedure carries risks like breathing failure or infection, and success depends on individual recovery.

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

30 people

The number who actually took part.

Started

Jun 2018

Finished

Dec 2020

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 years and older

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 at least 18 years old * brain-injury disease * tracheotomy act while in neurosurgery or reanimation stay * no artificial ventilation * medical cover * free, informed and express consent by the patient or his legal representative (no later than the day after the inclusion and before all exam necessary for the research) Exclusion Criteria: Malnutrition (defines by the age) : * age \< 70 years old: body mass index (B.D.I.) \<16 kg/m² or albuminemia \<20 g/L * age \> 70 years old: body mass index (B.D.I.) \<18 kg/m² or albuminemia \<30 g/L

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Conditions

The condition(s) this trial relates to.

brain injury

As listed by the trial registrant

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

Brain injuries Tracheostomy

Contacts and locations

Locations

  • CHU de Bordeaux

    Bordeaux, 33000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.