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Breath test may predict ventilator success in ICU patients

NCT ID NCT05802745

Knowledge-focused Sponsor: Cleveland Clinic Abu Dhabi Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at 120 critically ill patients on breathing machines to see if a quick, non-invasive test called P0.1 could predict whether they would need the tube reinserted after removal. The test measures the effort to breathe in the first split second of inhalation. Researchers hope this could help doctors make safer decisions about removing breathing support.

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

120 people

The number who actually took part.

Started

Jun 2023

Finished

Aug 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.

Who is studied

Critically ill patients with invasive mechanical ventilation.

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: \- All patients aged 18 years or older who received mechanical ventilation for at least 48 hours and satisfied the weaning criteria will be eligible for enrollment. The readiness-to-wean criteria that will be employed are: (1) the resolution or improvement of the underlying cause of respiratory failure for which the patient was intubated; (2) hemodynamic stability, defined as heart rate (HR) \< 140/min and systolic blood pressure between 90 and 160 mmHg with no or minimal doses of vasopressors; (3) stable respiratory status, defined as oxygen saturation \> 90% with fraction of inspired oxygen (FiO2) ≤ 0.5 and positive end expiratory-pressure (PEEP) ≤8 cmH2O, respiratory rate (RR) ≤ 35/min, spontaneous tidal volume (Vt) \> 5 mL/kg, and no significant respiratory acidosis; (4) adequate mental status, and (5) adequate cough. Exclusion Criteria: * Presence of tracheostomy * Do-not-reintubate orders * pregnancy * Absence of informed consent * Spontaneous breathing trial failure.

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Conditions

The condition(s) this trial relates to.

Critical Illness

As listed by the trial registrant

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

Critically ill Mechanical ventilation Weaning failure

Contacts and locations

Locations

  • Amiens University Hospital

    Amiens, France

  • Dijon University Hospital

    Dijon, France

More trials for these conditions

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