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Can breathing training help ventilator patients breathe on their own?

NCT ID NCT04658498

Knowledge-focused Sponsor: KU Leuven Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how different types of breathing muscle training affect patients in the ICU who are having trouble coming off a ventilator. Researchers will compare usual care with two forms of inspiratory muscle training (one high-intensity, one low-intensity) in 90 adults. The goal is to understand how the breathing muscles change and improve, not to test a new drug or device.

What this could mean

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

Active substance
Inspiratory muscle training using a tapered flow resistive device (POWERbreathe KH2)
What this could lead to
If successful, this study could point toward better, more effective ways to help ICU patients breathe on their own again after being on a ventilator.
What could go wrong
This is a small, early-stage mechanistic study (90 participants) focused on understanding muscle changes, not on proving a treatment works. Results may not lead to a clear clinical benefit.

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

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Oct 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.

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: * Difficult and prolonged weaning patients * Adequate oxygenation * Febrile temperature \< 38ºC * Hemodynamic stability * Stable blood pressure * No or minimal vasopressors * No myocardial ischemia * Adequate hemoglobin and mentation * Resolution of disease acute phase * Able to follow simple verbal commands related to IMT * Mechanically ventilated via a tracheostomy or endotracheal tube Exclusion Criteria: * Pre-existing neuromuscular disease * Agitation * Hemodynamically instable (arrhythmia, decompensated heart failure, coronary insufficiency) * Hemoptysis * Diaphoresis * Spinal cord injury above T8 * Use of any type of home MV support prior to hospitalization * Skeletal pathology that impairs chest wall movements * Poor general prognosis or fatal outcome

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As listed by the trial registrant

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

Weaning failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospital Leuven

    RECRUITING

    Leuven, 3000, Belgium

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