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Which ventilation method best protects ARDS lungs? small study aims to find out

NCT ID NCT07315815

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test 20 adults with moderate-to-severe ARDS to see whether a controlled breathing machine (with or without muscle paralysis) or a machine that lets them breathe on their own is better at preventing lung injury. Each patient will try four different ventilation settings for 30 minutes each. The goal is to find which approach best protects the lungs while keeping the patient comfortable.

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 choose the safest ventilation method for ARDS patients, potentially reducing lung damage.
What could go wrong
This is a very small, early-phase study with only 20 participants, so results may not apply to all patients. It measures short-term effects, not long-term outcomes.

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 20 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Apr 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.

Who is studied

Intubated patients fulfilling ARDS criteria and undergoing assisted ventilation as per clinical decision will be enrolled in case of moderate-to-severe hypoxemia.

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: * Intubated patients fulfilling moderate-to-severe ARDS (ratio of arterial partial pressure of oxygen to fraction of inspired oxygen. * Undergoing assisted ventilation as per clinical decision Exclusion Criteria: * refusal to participate, age younger than 18 years old, pregnancy * contraindication to EIT use (e.g., presence of pacemaker or automatic implantable cardioverter defibrillator), impossibility to place the EIT belt in the right position (e.g., presence of surgical wounds dressing), and any contraindication to the insertion of a nasogastric tube (e.g., recent upper-gastrointestinal surgery, esophageal varices).

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Conditions

The condition(s) this trial relates to.

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.

Ventilator induced lung injury

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

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