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Ventilator breathing workout may help ICU patients breathe on their own faster

NCT ID NCT07689110

Disease control Sponsor: University of Santiago de Compostela Source: ClinicalTrials.gov ↗

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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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 Results may not be published yet.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. 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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study tests whether a physiotherapist-guided breathing exercise — gradually reducing the ventilator's pressure support — can strengthen the diaphragm in critically ill adults on mechanical ventilation. Participants are randomly assigned to receive these training sessions twice daily or standard care. The goal is to see if this approach improves inspiratory muscle strength, diaphragm thickness, and the ability to breathe without the ventilator.

What this could mean

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

Active substance
Progressive pressure support reduction (inspiratory muscle endurance training)
What this could lead to
If effective, this simple physiotherapy technique could become a standard part of ICU care, reducing time on ventilators and improving recovery for critically ill patients.
What could go wrong
This is a small, early-stage trial (60 participants) testing a behavioral intervention. Results may not apply to all ICU patients, and the training may not improve weaning success or survival.

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 60 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

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: 1. Age ≥ 18 years 2. Admitted to ICU with invasive mechanical ventilation for more than 48 hours at the time of randomization 3. Expected to remain intubated for at least 24 additional hours, at the discretion of the attending intensivist 4. Active pressure support ventilation (PSV) mode with PS level ≥ 5 cmH2O 5. Richmond Agitation-Sedation Scale (RASS) score between -1 and +1 6. Arterial pH ≥ 7.35 and serum lactate ≤ 2.0 mmol/L 7. Peripheral oxygen saturation (SpO2) ≥ 90% with current FiO2 8. Informed consent obtained from patient or legal representative Exclusion Criteria: 1. Neurological condition affecting central respiratory control (high cervical spinal cord injury, ALS, myasthenia gravis, active Guillain-Barré syndrome) 2. Established tracheostomy at the time of inclusion 3. Restriction on head-of-bed elevation to ≥ 30 degrees 4. Decision to limit therapeutic effort (LET) or life expectancy \< 48 hours 5. Active hemodynamic instability (requirement for ≥ 2 vasopressors or vasopressor adjustment within the last 6 hours) 6. Multiple rib fractures or undrained pneumothorax 7. Simultaneous participation in another interventional clinical trial 8. Previous inclusion in this study

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As listed by the trial registrant

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

Endurance training Mechanical ventilation weaning Physiotherapy Respiratory muscle weakness

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Hospital Álvaro Cunqueiro

    Vigo, Spain

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