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Sigh breaths may help ventilators 'See' lung recruitability

NCT ID NCT07172061

Knowledge-focused Sponsor: AUSL Romagna Rimini 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether a ventilator-delivered sigh breath can help measure how much of the lung can be reopened (recruitability) in patients on breathing support. 110 adults on pressure support ventilation received two short test periods with different pressure settings. The goal was to see if a simple sigh-based measurement could guide doctors in choosing the best ventilator pressure.

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 give doctors a simple bedside tool to set ventilator pressure more precisely for each patient, potentially improving breathing support.
What could go wrong
This is a small, completed physiological study, not a treatment trial. The findings may not apply to all ventilated patients or change standard care.

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

110 people

The number who actually took part.

Started

Jul 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: * Adults (≥18 years) receiving PSV with the ventilator's sigh function active. Exclusion Criteria: * Clinical contraindication to increasing PEEP * Hemodynamic instability defined as SOFA cardiovascular score ≥3

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As listed by the trial registrant

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

Mechanical ventilation

Contacts and locations

Locations

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Italy, 29000, Italy

  • Ospedale Maurizio Bufalini

    Cesena, Italy, 47521, Italy

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