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New tool could help Brain-Injured patients breathe on their own sooner

NCT ID NCT04080440

Knowledge-focused Sponsor: University Hospital, Clermont-Ferrand 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether a simple clinical score can help doctors decide when to safely remove breathing tubes from brain-injured patients who are still unconscious. The trial will include 660 adults with acute brain injuries who have been on a ventilator for more than 48 hours. The goal is to reduce the number of patients who need to be re-intubated or die within five days of tube removal.

What this could mean

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

Active substance
Extubation readiness clinical score (a procedure to guide decision-making)
What this could lead to
If successful, this could provide a simple, reliable tool to help doctors decide when to remove breathing tubes in brain-injured patients, potentially reducing complications and time on a ventilator.
What could go wrong
This is a single trial testing a clinical score, not a drug or device. The score may not improve outcomes in all patients, and results may not apply to other settings or patient groups.

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 660 people

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

Started

Feb 2020

Expected to finish

Oct 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 75 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: * Acute cerebral lesion with a Glasgow Coma Scale \<13 needing admission in ICU and mechanical ventilation with tracheal intubation for neurological cause : cerebrovascular stroke either ischemic or hemorrhagic including aneurysmal subarachnoid hemorrhage, traumatic brain injury, anoxo ischemic encephalopathy after cardiac arrest or brain tumour * Mechanical ventilation more than 48 hours * 18 to 75 years old * Neurological stability with no intracranial hypertension with minimal sedation * Glasgow Coma Scale motor response \< 6 * Spontaneous breathing trial succeeded * First extubation attempt Exclusion Criteria: * Posterior cranial fossa lesion * Admission for status epilepticus or central nervous system infection * Spinal cord injury (tetraplegia or paraplegia) * Uncontrolled status epilepticus or uncontrolled central nervous system infection * Care limitation plan * Chronic respiratory failure defined as ambulatory oxygen therapy or pressure support ventilation and/or proven COPD and/or ambulatory non-invasive CPAP therapy for sleep apnoea syndrome * More than 3 failed spontaneous breathing trials * Significant chest trauma (more than 2 broken ribs / broken sternum / with an indication of open thoracic surgery) * Surgery planned within 7 days * Tracheotomy or previous extubation outside of the protocol * Previous compromised upper airway permeability * Pregnant or breastfeeding woman * Adult under the protection of the law or without social assurance system * Inclusion in another clinical study about mechanical ventilation or weaning

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia Brain Injuries, Traumatic brain injury Coma Consciousness Disorders stroke disorder

As listed by the trial registrant

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

Acute brain injury Airway control Altered level of consciousness Mechanical ventilation Mechanical ventilator weaning

How to take part

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

  1. The places running it

    14 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

  • APHM

    WITHDRAWN

    Marseille, France

  • CH

    TERMINATED

    Bourg-en-Bresse, France

  • CH

    TERMINATED

    Valence, France

  • CHU

    RECRUITING

    Angers, France

  • CHU

    RECRUITING

    Bordeaux, France

  • CHU

    RECRUITING

    Bordeaux, France

  • CHU

    RECRUITING

    Caen, France

  • CHU

    RECRUITING

    Clermont-Ferrand, France

  • CHU

    COMPLETED

    Grenoble, France

  • CHU

    RECRUITING

    La Réunion, France

  • CHU

    RECRUITING

    Lille, France

  • CHU

    RECRUITING

    Montpellier, France

  • CHU

    COMPLETED

    Nantes, France

  • CHU

    RECRUITING

    Nîmes, France

  • CHU

    RECRUITING

    Poitiers, France

  • CHU

    RECRUITING

    Rennes, France

  • CHU

    COMPLETED

    Saint-Etienne, France

  • CHU

    RECRUITING

    Toulouse, France

  • Fondation Ophtalmologique Adolphe de Rothschild

    RECRUITING

    Paris, France

  • Hospices Civils de Lyon

    RECRUITING

    Lyon, France

  • Pasteur 2 Hospital - University Hospital

    TERMINATED

    Nice, France

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