Inspiratory Muscle Training for Mechanical Ventilator Weaning
(FLEX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two exercises to aid patients struggling to come off mechanical ventilators. One method, Inspiratory Muscle Training, uses a device to strengthen breathing muscles. The other, Quasi-Isometric Neck Flexion, involves a neck exercise that can be performed while still on the ventilator. Researchers aim to determine which exercise is easier, more comfortable, and safer for patients. Suitable candidates are those who have had difficulty breathing independently after using a mechanical ventilator but can still follow simple instructions. As an unphased trial, this study allows patients to contribute to innovative research that could enhance recovery for future ventilator patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these techniques are safe for patients with prolonged mechanical ventilation?
Research shows that Inspiratory Muscle Training (IMT) is a safe and well-established method to assist patients with weak breathing muscles, particularly those in intensive care. Studies indicate that IMT can strengthen these muscles and facilitate easier weaning from ventilators.
Conversely, neck flexion, which involves simple head movements, has undergone less study in patients requiring long-term mechanical ventilation. Early findings in healthy individuals suggest that neck flexion might be safe and well-tolerated, but it hasn't been thoroughly tested in patients with respiratory issues. Researchers hope neck flexion could serve as a safe alternative or complement to IMT, especially since it doesn’t require removing patients from ventilators.
In summary, while IMT is proven safe, neck flexion appears promising but requires further research to confirm its safety for patients needing prolonged ventilation.12345Why are researchers excited about this trial?
Researchers are excited about the Inspiratory Muscle Training (IMT) and Quasi-Isometric Neck Flexion techniques because they offer new strategies for helping patients wean off mechanical ventilators. Unlike traditional methods that often rely on gradually reducing ventilator support, these techniques actively strengthen respiratory and neck muscles. IMT uses a POWERbreathe device to provide variable resistance, which helps build inspiratory muscle strength more effectively. Meanwhile, the Quasi-Isometric Neck Flexion involves patients lifting their heads to enhance neck muscle endurance during minimal ventilator support. These approaches could potentially speed up recovery and reduce time spent on ventilators, a significant improvement over current weaning practices.
What evidence suggests that this trial's techniques could be effective for weaning from mechanical ventilation?
This trial will compare Inspiratory Muscle Training (IMT) with Quasi-Isometric Neck Flexion for patients on mechanical ventilation. Research has shown that IMT can improve breathing muscle function in patients struggling to come off a ventilator. Studies have found that IMT strengthens these muscles and aids in the weaning process. However, some research suggests that while IMT increases muscle strength and improves breathing patterns, it doesn't always result in more successful weaning overall.
Quasi-Isometric Neck Flexion, another treatment arm in this trial, involves exercises that activate important breathing muscles, similar to IMT. These exercises can be performed without removing patients from the ventilator, making them practical for those in the ICU. Although limited data exists on using neck exercises for patients requiring long-term ventilation, early signs suggest they might be as effective as IMT in working the breathing muscles.12456Are You a Good Fit for This Trial?
This trial is for patients over 16 years old who are on mechanical ventilation due to difficulty weaning off it. They must have failed extubation or breathing trials, be able to trigger the ventilator spontaneously, and be in stable condition with adequate oxygen levels. Participants need to understand simple instructions.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Measurements
Baseline measurements including ultrasound and sEMG of respiratory muscles are performed
Training Phase
Participants undergo Inspiratory Muscle Training (IMT) and Quasi-Isometric Neck Flexion once a week
Follow-up
Participants are monitored for safety and effectiveness after training
What Are the Treatments Tested in This Trial?
Interventions
- Inspiratory Muscle Training
- Quasi-Isometric Neck Flexion
Inspiratory Muscle Training is already approved in European Union, United States, Canada for the following indications:
- Chronic Obstructive Pulmonary Disease (COPD)
- Congestive Heart Failure
- Spinal Cord Injury
- Multiple Sclerosis
- Chronic Obstructive Pulmonary Disease (COPD)
- Congestive Heart Failure
- Spinal Cord Injury
- Multiple Sclerosis
- Cardiac Rehabilitation
- Chronic Obstructive Pulmonary Disease (COPD)
- Congestive Heart Failure
- Spinal Cord Injury
- Multiple Sclerosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Unity Health Toronto
Lead Sponsor