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New device settings may help ventilator patients breathe easier

NCT ID NCT06491017

Symptom relief Sponsor: Hospital Clinic of Barcelona 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 2 times

Summary

This study tests whether using a special cough-assist device (MI-E) with optimized settings can remove more mucus from the airways of critically ill patients on breathing machines. Researchers will compare the amount of mucus suctioned after using optimized versus standard settings in 26 adults. The goal is to find the best way to clear secretions and prevent complications.

What this could mean

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

Active substance
Mechanical insufflator-exsufflator (MI-E) device
What this could lead to
If it works, this could lead to better mucus clearance guidelines for ventilated patients, reducing complications like infections.
What could go wrong
This is a small, early-phase study with only 26 participants, so results may not apply broadly. The intervention is a device setting change, not a new drug, so the impact is limited.

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 26 people

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

Started

May 2026

Expected to finish

Dec 2028

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 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Adults (\> 18yo). * Endotracheal intubation and invasive mechanical ventilation for \> 48h and active humidification for \> 24h. * Richmond Agitation-Sedation Scale -3 to -5. * Signed informed consent. Exclusion Criteria: * Patients with hemodynamic instability (MAP \< 60 or \> 110, Heart Rate \< 50 or \> 130, new onset arrhythmias), respiratory instability (PEEP \> 12cmH2O, SpO2 \< 90% or fraction of inspired oxygen (FiO2) \> 60%). * Undrained pneumothorax/pneumomediastinum. * Unstable intracranial pressure (ICP \> 20mmHg or MAP \< 60). * Severe bronchospasm. * Post cardiothoracic surgical patients. * Active pulmonary tuberculosis. * Bronchoesophageal or bronchopleural fistulas. * Prone position. * Pregnancy.

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Conditions

The condition(s) this trial relates to.

mucocele of salivary gland

As listed by the trial registrant

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

Mechanical ventilation complication Mucus retention

How to take part

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

  1. The places running it

    1 site. 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

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

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