Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Improving respiratory muscle training for patients weaning off mechanical ventilation

Official title: Improving Our Understanding of Respiratory Muscle Training to Facilitate Weaning From Mechanical Ventilation in the ICU

Run by KU Leuven · NCT04658498 · Data updated 2026-11-12

This study is testing different types of breathing exercises to see which helps patients coming off mechanical ventilation in the ICU breathe better and recover faster.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment90 (estimated)
SponsorKU Leuven
Academic / other
Locations1 site (Leuven)
StatusRecruiting
StartedFebruary 1, 2023
Main results expectedOctober 2026
Study endsOctober 2026
Registry record updatedMarch 18, 2026
Trial IDNCT04658498 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients experiencing difficult and prolonged weaning from mechanical ventilation who are hemodynamically stable and able to follow simple commands.

Probably not a fit

Patients with pre-existing neuromuscular diseases or those who are hemodynamically unstable are unlikely to benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of different inspiratory muscle training (IMT) regimens on respiratory muscle function in patients who are being weaned from mechanical ventilation in the ICU. It aims to address the common issue of respiratory muscle weakness that can prolong mechanical ventilation and increase mortality rates. Participants will be exposed to three different training conditions, including usual care, high-intensity IMT, and low-intensity sham IMT, to evaluate their physiological responses. The study seeks to provide a better understanding of the optimal approach to IMT for improving weaning outcomes.

Why it matters

Potential benefit: If successful, this study could lead to improved weaning outcomes and reduced ICU mortality for patients requiring mechanical ventilation.

How similar studies have gone: While some studies have explored inspiratory muscle training, this specific approach and its mechanistic evaluation in ICU patients is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • University Hospital Leuven
    Leuven, Belgium
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.