Improving Our Understanding of Respiratory Muscle Training to Facilitate Weaning From Mechanical … (NCT04658498) | Clinical Trial Compass
RecruitingNot Applicable
Improving Our Understanding of Respiratory Muscle Training to Facilitate Weaning From Mechanical Ventilation in the ICU
Belgium90 participantsStarted 2023-02-01
Plain-language summary
Mechanical ventilation is a life-saving treatment frequently applied in intensive care unit (ICU). Nonetheless, by putting at rest the respiratory muscles, it can lead to respiratory muscle weakness and atrophy, which are accompanied by prolonged duration of mechanical ventilation, difficult weaning and increased ICU mortality. Despite a strong theoretical rationale and some evidence supporting the use of inspiratory muscle training (IMT) to address respiratory muscle weakness and atrophy, the optimal approach to IMT remains largely uncertain. In fact, mechanistic studies evaluating physiological adaptations that occur in respiratory muscles of mechanically ventilated patients in response to different training regimens have not been conducted so far.
The aim of this study is to comprehensively investigate changes in respiratory muscle function in response to three different conditions that patients will be exposed to during their period of weaning from mechanical ventilation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximal Inspiratory Pressure (PImax)
Timeframe: Maximal duration of IMT treatment: 28 days