A clinical trial led by McGill University Health Center (Canada) researchers is currently recruiting participants to enroll in a study to assess the use of noninvasive home ventilation by patients with amyotrophic lateral sclerosis (ALS) using the iVAPS mode offered on ResMed ventilators.
ALS is a progressive neurodegenerative disease that affects nerve cells (neurons) in the brain and spinal cord. ALS patients may become totally paralyzed and the majority dies due to respiratory failure. There is no cure for ALS.
The American Academy of Neurology (AAN) recommends the use of home noninvasive ventilation as the standard-of-care in ALS patients experiencing worsening of the symptoms or declining respiratory function.
The Intelligent Volume-Assured Pressure Support (iVAPS) corresponds to a ventilator mode on the Stellar 150 ventilator (Resmed) based on an algorithm for the alveolar ventilation. This system has a learning mode that is capable of determining the optimal settings to start ventilation, and also an adaptive mode that allows it to continuously monitor the spontaneous ventilation of the patient and adjust the parameters of pressure support accordingly to maintain alveolar ventilation.
This is a randomized clinical study to assess the efficacy and safety of the new iVAPS mode of ventilation in comparison with the traditional Bilevel ventilation in spontaneous/timed mode (BiST). The feasibility of the employment of long-term noninvasive home ventilation with the Stellar 150 iVAPS mode in ALS patients will be assessed, and the primary outcome measure is the number of respiratory therapist interventions required during a follow-up period of one year.
The hypothesis of the researchers is that the iVAPS mode will induce a decrease in the number of respiratory therapist interventions and alterations in the ventilator settings in comparison with the BiST mode. The trial hopes to recruit 30 participants.