Improving respiratory muscle training for patients weaning off mechanical ventilation
Improving Our Understanding of Respiratory Muscle Training to Facilitate Weaning From Mechanical Ventilation in the ICU
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT04658498 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients experiencing difficult and prolonged weaning from mechanical ventilation who are hemodynamically stable and able to follow simple commands.
Not a fit: Patients with pre-existing neuromuscular diseases or those who are hemodynamically unstable are unlikely to benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Leuven
- University Hospital Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Daniel Langer, PT, PhD
- Email: daniel.langer@kuleuven.be
- Phone: +3216330192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.