Designing a personalized oral interface for neuromuscular patients with non-invasive ventilation

BACKGROUND: Patients with neuromuscular diseases present a high risk of acute or chronic respiratory failure, such as to require treatment with non-invasive ventilation. Even though non-invasive ventilation (NIV) has proven to be very effective and efficient, the occurrence of therapeutic failures is often reported, generally in association with a low tolerance of the interface used. The aim of this study is to investigate the therapeutic effectiveness and efficiency of a new personalized internal oral device, in support of the open-circuit mouthpiece ventilation (OMV) interface, by comparing it to the oronasal interface. METHODS: The study includes patients affected by neuromuscular diseases, who are already treated with non-invasive mechanical ventilation through oronasal masks. Each patient has undergone two overnight polysomnographies: the first carried out with an oronasal mask, while the second with the personalized oral interface that was designed. Within the study, daytime ventilation with both interfaces has also been evaluated. RESULTS: The use of the personalized oral interface has led to an average increase in air leaks, making the device inadequate for nocturnal use, and adequate for daytime use exclusively. However, the study has surfaced a reduction of facial lesions/irritations, associated to an increase in comfort for the patient. CONCLUSIONS: Considering the results, the personalized oral interface can be considered as an alternative to the ventilation interfaces that are commonly used with patients who suffer from respiratory failure, exclusively in the day-time hours.