New study tests if ventilator energy measurements can predict breathing tube removal success

NCT ID NCT07268989

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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 Results may not be published yet.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)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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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

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 60 adult ICU patients on breathing machines to see if a measure called mechanical power (the energy delivered to the lungs) can predict whether they will successfully breathe on their own after the tube is removed. Researchers also checked other breathing tests like airway pressure and breathing rate. The goal is to find better ways to decide when it's safe to take someone off a ventilator, reducing the risk of needing to put the tube back in.

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Study facts

What this study's own registry entry says, in plain language.

Participants

60 people

The number who actually took part.

Started

Jul 2025

Finished

Apr 2026

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

Adult patients who are receiving invasive mechanical ventilation in the intensive care unit (ICU) and are scheduled for planned extubation based on standard clinical weaning criteria. All participants must be hemodynamically stable and able to undergo bedside ventilator-based respiratory assessment, including mechanical power (MP), airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI), prior to extubation.

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 ≥ 18 years (adult patient population) * Patients receiving invasive mechanical ventilation in the intensive care unit * Having been intubated for at least 24 hours * Patients for whom the clinical team has decided extubation and who meet the following weaning criteria: * Stable respiratory parameters (FiO₂ ≤ 50%, PEEP ≤ 7 cmH₂O, SpO₂ ≥ 92%) * Hemodynamic stability (no inotropic support or minimal/stable dose) * Stable acid-base balance * Adequate secretion control * Technically suitable ventilator and measurement conditions * Written informed consent obtained from the patient or legal representative Exclusion Criteria: * Patients with any of the following conditions will be excluded: and * Individuals under 18 years of age * Pregnant patients * Patients who do not meet the weaning criteria * Tracheostomized patients * Neuromuscular diseases (e.g., Guillain-Barré syndrome, Duchenne muscular dystrophy, etc.) * Technical inadequacy preventing correct ventilator measurements * Significant asynchrony (e.g., auto-PEEP, double triggering, ineffective triggering, cycle asynchrony, auto-triggering) * Patients without an extubation plan or those receiving palliative care * RASS ≤ -2 (excessive sedation) for PSV mode measurements * RASS ≥ +2 (agitation) for PSV-CPAP mode measurements * Patients with delirium for PSV-CPAP mode measurements * Patients who cannot provide consent, have no legal representative, or whose representative refuses consent

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

    Istanbul, 34303, Turkey (Türkiye)

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