A Novel CPAP Device With an Integrated Oxygen Concentrator for Low Resource Countries: In Vitro Validation and Usability Test in Field.

ABSTRACT

Goal To develop and validatea novel neonatal non-invasive respiratory support device prototype designed to operate in low-resource settings. Methods: The device integrates a blower-based ventilator and a portable oxygen concentrator. A novel control algorithm was designed to achieve the desired fraction of inspired oxygen (FiO2) while minimizing power consumption. The accuracy of the delivered FiO2 and the device power consumption were evaluated in vitro, and a formative usability test was conducted in a rural hospital in Uganda. Results: The agreement between the set and delivered FiO2 was high (limit of agreement-5.6 ÷ 3.8%). For FiO2 below 60%, the control algorithm reduced the power drain by 50%. The device was also appreciated by intended users. Conclusion: The prototype proved effective in delivering oxygen-enriched continuous positive airway pressure in the absence of compressed air and oxygen, holding promise for a sustainable and effective implementation of neonatal respiratory support in low-resource settings.