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Smart ventilator shows promise for brain injury patients

NCT ID NCT06367816

Disease control Sponsor: University of Genova 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a closed-loop ventilation system (INTELLiVENT-ASV) in 20 adults with acute brain injury who needed a breathing machine. The goal was to see if this smart system could provide safer, more effective breathing support compared to standard ventilation. Researchers measured how often the ventilator stayed in safe zones and monitored brain changes.

What this could mean

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

Active substance
Closed-loop ventilation mode (INTELLiVENT-ASV)
What this could lead to
If successful, this could lead to safer, more automated breathing support for brain injury patients in intensive care.
What could go wrong
This is a small, completed study with only 20 participants. Results may not apply to all brain injury patients, and the technology may not improve outcomes significantly.

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.

Participants

20 people

The number who actually took part.

Started

Apr 2024

Finished

Dec 2024

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.

Who is studied

Invasively ventilated acute brain injury (ABI) patients admitted to the ICU of the Policlinico San Martino Hospital, Genova, Italy

Ages

18 to 105 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: * aged ≥ 18 years; * intubated and receiving invasive ventilation for ABI; * admitted to the Intensive Care Unit Exclusion Criteria: \- receiving ventilation with a ventilator that does not allow INTELLiVENT-ASV

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Conditions

The condition(s) this trial relates to.

brain injury Respiratory Aspiration

As listed by the trial registrant

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

Automation Brain injuries, acute Respiration, artificial

Contacts and locations

Locations

  • UO Clinica Anestesiologica e Terapia Intensiva, IRCCS Ospedale Policlinico San Martino

    Genova, GE, 16132, Italy

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