Training respiratory muscles during neck flexion for patients on mechanical ventilation
Muscle Recruitment During Neck Flexion and Inspiratory Muscle Training in Difficult and Prolonged Weaning Patients: a Physiological Study - The FLEX Study
This study tests if combining breathing exercises with neck flexion can help patients on mechanical ventilation strengthen their respiratory muscles and successfully wean off the ventilator.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Unity Health Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05710432 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of inspiratory muscle training (IMT) combined with neck flexion exercises in patients who are receiving mechanical ventilation. It aims to strengthen respiratory muscles, particularly in patients who have struggled with weaning from ventilators. The approach includes baseline measurements using ultrasound and electromyography to assess muscle function, followed by weekly training sessions until successful weaning or a maximum of four weeks. The study focuses on patients who can spontaneously trigger the ventilator and are in stable clinical conditions.
Who should consider this trial
Good fit: Ideal candidates are patients aged 16 and older who are receiving mechanical ventilation and have failed extubation or spontaneous breathing trials.
Not a fit: Patients with severe neuromuscular disorders or those unable to follow simple verbal instructions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the weaning process from mechanical ventilation, enhancing recovery for patients with respiratory muscle dysfunction.
How similar studies have performed: While the specific combination of techniques in this study is novel, previous studies have shown promising results with non-respiratory training techniques targeting accessory muscles.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients receiving invasive MV via endotracheal tube who had failed a planned extubation or failed at least three spontaneous breathing trials (SBTs) or receiving MV via tracheostomy (who required tracheostomy because of difficult or prolonged weaning, failed extubation and/or prolonged ventilation) and able to spontaneously trigger the ventilator. * Over or equal to 16 years of age * Tolerating levels of pressure support of 10 cmH2O or lower (or equivalent support in NAVA or PAV+) for at least 15 minutes * In stable clinical and hemodynamic conditions and adequate level of oxygenation (cardiac frequency ≤ 140 beats/minute, systolic blood pressure 90-160 mmHg, no or minimal vasopressors, PaO2/FiO2 over or equal to 150 mmHg) * Able to understand and follow simple verbal instructions Exclusion Criteria: * Patients with a previously diagnosed severe neuromuscular disorder (such as amyotrophic lateral sclerosis, muscular dystrophy, multiple sclerosis, myasthenia gravis or spinal cord injury) * Patients with chronic respiratory failure already ventilated before ICU admission * Patients unable to collaborate or understand instructions
Where this trial is running
Toronto, Ontario
- St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Laurent Brochard, MD, PhD
- Email: Laurent.Brochard@unityhealth.to
- Phone: 416-864-5686
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.