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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Status | Recruiting |
| Started | February 1, 2023 |
| Main results expected | October 2026 |
| Study ends | October 2026 |
| Registry record updated | March 18, 2026 |
| Trial ID | NCT04658498 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
- Study coordinator: Daniel Langer, PT, PhD
- Email: daniel.langer@kuleuven.be
- Phone: +3216330192
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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heepSync: synchronized electrical stimulation of breathing muscles for adults on mechanical ventilation
This trial tests whether the heecap heepSync algorithm can safely sync electrical stimulation to breathing muscles in adults on mechanical ventilation.
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Characterization of weaning practices in ICUs in Global South countries
This observational study tests how adult ICU patients on mechanical ventilation who are starting to wean are extubated, observing them for 7 days after extubation and until hospital discharge or death.
-
Monitoring diaphragm electrical activity and breathing effort during ventilator weaning
We will see if surface diaphragm EMG, esophageal pressure, and oxygen use measured during a spontaneous breathing trial can predict who will fail to wean from the ventilator in the ICU.
-
Using levosimendan to shorten time on a ventilator
This will test whether giving levosimendan to adults in the ICU who have failed a breathing trial helps them get off the ventilator sooner.
-
How differences in lung stiffness and breathing pressures affect getting off the ventilator after a tracheostomy
This project will test whether measurements of regional lung compliance and transpulmonary driving pressure using electrical impedance tomography and esophageal pressure can explain why some tracheostomized patients on prolonged mechanical ventilation cannot be weaned.
-
Impact of low phosphate levels on weaning off mechanical ventilation
This study is testing if giving a phosphate supplement can help patients with low phosphate levels breathe better and get off mechanical ventilation more easily.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.