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Smarter ventilator monitoring could prevent lung injury in ICU patients

NCT ID NCT07686315

Knowledge-focused Sponsor: Istituto Clinico Humanitas 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study tests whether advanced monitoring of breathing patterns can help prevent lung damage in intensive care unit (ICU) patients who need a ventilator for reasons other than lung failure, such as coma or sepsis. Researchers will use special sensors to track airway pressure, lung effort, and electrical impedance tomography (EIT) during the first 24 hours of ventilation. The goal is to see if these measurements can predict which patients might develop acute respiratory distress syndrome (ARDS), a serious lung condition.

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 could help doctors adjust ventilators to prevent lung damage in ICU patients, reducing the risk of acute respiratory distress syndrome (ARDS).
What could go wrong
This is a small, early-stage observational study. The monitoring may not reliably predict ARDS, and results may not apply to all ICU patients.

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

About 40 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

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.

Who is studied

The study population consists of adult patients admitted to the Intensive Care Unit (ICU) who require invasive mechanical ventilation for reasons entirely distinct from acute respiratory failure, such as coma, trauma, or sepsis. Eligible individuals must be enrolled and have monitoring initiated within the first 24 hours of oro-tracheal intubation. The cohort excludes patients with specific barotrauma complications, pregnant individuals, and those with absolute clinical contraindications to the required monitoring procedures.

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.

Study Population Eligibility Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Inclusion Criteria: Adult patients +18 years. Undergoing invasive mechanical ventilation for reasons other than acute respiratory failure (such as coma, trauma, or sepsis). Initiation of monitoring within 24 hours of oro-tracheal intubation. Exclusion Criteria: Evidence of pneumothorax, pneumomediastinum, or subcutaneous emphysema. Pregnancy. Absolute contraindications to nasogastric tube placement. Absolute contraindications to electrical impedance tomography (EIT) monitoring.

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome prevention target

As listed by the trial registrant

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

Developing acute respiratory distress syndrome

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

  • Humanitas Research Hospital

    RECRUITING

    Milan, Lombardy, 20089, Italy