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Breath-Hold trick may spare ICU patients invasive tubes

NCT ID NCT06344234

Knowledge-focused Sponsor: University of Bari 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 observational study tests whether a quick breath-hold maneuver can accurately measure how hard patients are working to breathe during noninvasive ventilation. Researchers will compare this simple test to the current standard, which requires a tube down the esophagus. If the breath-hold method works, it could make breathing monitoring less invasive and more comfortable for patients.

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 lead to simpler, less invasive ways to monitor breathing effort in patients on noninvasive ventilation.
What could go wrong
This is a small observational study (60 people) that only measures correlations, not outcomes. The technique may not be accurate enough to replace current methods.

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

60 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Jun 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

All hypoxemic patients with a PaO2/FiO2 ratio equal or lower than 300, receiving post-extubation noninvasive ventilation via an nose-to-mouth or a full-face mask, will be screened for eligibility.

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: * Age greater than or equal to 18 years. * Non-pregnant and non-lactating. * Monitored through esophageal pressure for clinical decision before extubation. * Able to provide written informed consent to participate in the study. Exclusion Criteria: * Patients with severe facial trauma or deformity that precludes the placement of a facemask or esophageal catheter. * Patients with neuromuscular disorders that may impair inspiratory drive and effort. * Patients with acute exacerbation of COPD * Patients with esophageal or tracheal abnormalities that impede esophageal manometry. * Patients with a known hypersensitivity or allergy to any of the materials used in the study. * Excessive air leak (difference between inspiratory and expiratory tidal volume major or equal to 30% \[prot. n 1136947\]).

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Conditions

The condition(s) this trial relates to.

Respiration Disorders Respiratory Aspiration respiratory system disorder

As listed by the trial registrant

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

Artificial respiration Respiratory disease

Contacts and locations

Locations

  • Azienda ospedaliero-universitaria consorziale policlinico di Bari

    Bari, Bari, 70124, Italy

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