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Tailored breathing support may reduce lung injury in respiratory failure

NCT ID NCT06202144

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether personalizing noninvasive breathing support based on a patient's inspiratory effort improves breathing mechanics compared to standard CPAP or NIV. Twenty adults with moderate-to-severe acute hypoxic respiratory failure were enrolled. Researchers measured tidal volume, lung pressure, and other breathing parameters to see if a tailored approach reduces the risk of self-inflicted lung injury.

What this could mean

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

Active substance
noninvasive respiratory support delivered through a helmet
What this could lead to
If successful, this could lead to a more personalized approach for choosing between CPAP and NIV in patients with breathing failure, potentially reducing lung injury.
What could go wrong
This is a very small, early physiological study (20 participants) that measured short-term effects only. It does not test long-term outcomes or survival, so results may not change practice directly.

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

20 people

The number who actually took part.

Started

Jan 2024

Finished

Jun 2025

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

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: * Acute hypoxemic respiratory failure and PaO2/FiO2\<200 mmHg * PaCO2\<45 mmHg * Respiratory failure not caused by exacerbation of chronic pulmonary disease, cardiac failure or fluid overload Exclusion Criteria: * Pregnancy * Contraindication to helmet support * Contraindication to esophageal manometry * Contraindication to electrical-impedance tomography monitoring * Recent surgery involving the abdomen or the thorax * Pneumothorax or documented barotrauma

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Conditions

The condition(s) this trial relates to.

acute respiratory failure

As listed by the trial registrant

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

Acute hypoxic respiratory failure

Contacts and locations

Locations

  • Fondazione Policlinico Universitaro A. Gemelli IRCCS

    Rome, Italy

More trials for these conditions

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