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

Area of Science:

• Biomedical Engineering
• Pediatric Respiratory Medicine
• Medical Device Development

Background:

• Acute lower respiratory tract infections are a major cause of mortality in children under 5, particularly in low- and middle-income countries (LMICs).
• Limited availability of advanced respiratory support systems, such as Bilevel Positive Airway Pressure (BiPAP), contributes to poor outcomes in critically ill young patients.
• While Continuous Positive Airway Pressure (CPAP) is common, sicker children often require more advanced ventilatory support.

Purpose of the Study:

• To develop and evaluate a novel bubble-based bilevel ventilator (Bubble bi-vent) for pediatric respiratory support.
• To compare the performance of the Bubble bi-vent with a standard BiPAP ventilator in mechanical lung models.
• To assess the feasibility of bubble bilevel ventilation for infants and small children with moderate to severe lung disease.

Main Methods:

• Development of a bubble bilevel device using a vertically moving tube in a water seal to provide both positive end-expiratory pressure and inspiratory pressure.
• Testing the device in passively breathing mechanical lung models simulating infant and small child respiratory systems.
• Comparative analysis of pressure and tidal volume delivery between the Bubble bi-vent and a Trilogy BiPAP ventilator.

Main Results:

• The Bubble bi-vent successfully delivered set pressures within the mechanical lung models.
• Performance metrics, including pressure and tidal volume delivery, were comparable to a standard Trilogy BiPAP ventilator.
• Demonstrated feasibility of bubble bilevel ventilation for pediatric patients, a novel application for this age group.

Conclusions:

• The Bubble bi-vent is a feasible and potentially effective bubble-based bilevel ventilation system for infants and small children.
• This novel device addresses a previously undescribed need for advanced respiratory support in pediatric populations with moderate to severe lung disease.
• The findings suggest a promising new option for improving outcomes in young patients with critical respiratory conditions, especially in resource-limited settings.