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Ventilator may harm the brain, not just the lungs – study eyes link

NCT ID NCT07629973

Knowledge-focused Sponsor: University Hospital, Angers Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 28, 2026 · Updated 4 times

Summary

This study looks at whether the force of mechanical ventilation in patients with acute respiratory distress syndrome (ARDS) can damage the brain. Researchers will measure a protein called S100B in the blood, which is a sign of brain injury, and track thinking and memory problems over a year. The goal is to understand if certain ventilator settings raise the risk of long-term cognitive issues. 150 adults with ARDS will be enrolled.

What this could mean

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

What this could lead to
If successful, this study could help identify which ARDS patients are at highest risk for long-term brain damage, leading to better protective ventilation strategies.
What could go wrong
This is an observational study, not a treatment trial. It will not test any new therapy, and the link between ventilation and brain injury remains unproven in humans.

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 150 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * Adult patient * Patient admitted to the intensive care unit less than 48 hours ago * Patient diagnosed with mild, moderate or severe ARDS according to the Berlin classification based on the PaO₂/FiO₂ ratio, with a minimum PEEP set at 5 cmH₂O (16), of pulmonary aetiology: * Mild ARDS: 200 \< PaO₂/FiO₂ \< 300 mmHg * Moderate ARDS: 100 \< PaO₂/FiO₂ \< 200 mmHg * Severe ARDS: PaO₂/FiO₂ \< 100 mmHg * Patients fitted with an oesophageal pressure measurement catheter (Nutrivent, Sidam, San Giacomo Roncole, Italy) * Patients registered with or covered by a social security scheme * Free and informed consent from the patient or a trusted relative (where the patient is unable to give consent). Exclusion Criteria: * Patients with a history of central nervous system disorders resulting in cognitive impairment * Patients on ECMO * Patients admitted for symptomatic central nervous system disorders * Patients admitted for acute respiratory distress syndrome following cardiorespiratory arrest. * Patients being treated for a psychiatric condition, chronic heavy drinkers, or those undergoing long-term treatment with benzodiazepines, antidepressants or antipsychotics. * Pregnant, breastfeeding or labouring patients * Individuals subject to a legal protection order * Individuals receiving compulsory psychiatric care * Individuals deprived of their liberty by judicial or administrative decision

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome Ventilator-Induced Lung Injury

As listed by the trial registrant

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

Acute respiratory distress syndrome (ARDS) Mechanical power S100B Transpulmonary pressure Ventilator induced lung injury

How to take part

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  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

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