Design and Bench Testing of a Novel, Pediatric, Non-Invasive, Bubble Bilevel Positive Pressure Ventilation Device

Acute lower respiratory tract infections are a leading cause of death in individuals under the age of 5 years, mostly in low- and middle-income countries (LMICs). The lack of respiratory support systems contributes to the poor outcomes. Bubble CPAP is widely used for non-invasive respiratory support, but sicker children often require support over what CPAP provides in the form of BiPAP. We developed and tested a simple bubble-based bilevel ventilator (Bubble bi-vent) and compared it with a standard care BiPAP device. The bubble bilevel device consisted of a single tube submerged in a water-sealed column to maintain end-expiratory positive airway pressure. It moves vertically via an electric motor to also provide inspiratory positive airway pressure for augmentation of lung volumes, with the duration and frequency of breaths controlled by a microprocessor. We tested this novel device in passively breathing mechanical lung models for infants and small children. We compared pressure and tidal volume delivery between the novel device and a Trilogy BiPAP ventilator. The results showed that the Bubble bi-vent could deliver set pressures in a mechanical lung and was comparable to a standard Trilogy ventilator. While two different bubble-based bilevel pressure devices have been piloted for neonates and adults, our results demonstrate the feasibility of bubble bilevel ventilation for infants and small children with moderate to severe lung disease for whom this was previously not described.