Evaluation and Performance of a Positive Airway Pressure Device (CPAP-AirFlife™): A Randomized Crossover Non-Inferiority Clinical Study in Normal Subjects.

Background and Objectives : During the COVID-19, the demand for non-invasive ventilatory support equipment significantly increased. In response, a novel non-invasive ventilatory support model called CPAP-AirFlife™ was developed utilizing existing technologies. This model offers technological advantages, including an aerosol-controlled helmet suitable for high-risk environments such as ambulances. Additionally, it is cost-effective and does not require medical air, making it accessible for implementation in low-level hospitals, particularly in rural areas. This study aimed to assess the efficacy of CPAP-AirFlife™ by conducting a non-inferiority comparison with conventional ventilation equipment used in the Intensive Care Unit. Materials and Methods : A clinical study was conducted on normal subjects in a randomized and sequential manner. Parameters such as hemoglobin oxygen saturation by pulse oximetry, exhaled PCO 2 levels, vital signs, and individual tolerance were compared between the CPAP-AirFlife™ and conventional equipment. The study population was described in terms of demographic characteristics and included in the analysis. Results : It was shown that the CPAP-AirFlife™ was not inferior to conventional equipment in terms of efficacy or tolerability. Hemoglobin oxygen saturation levels, exhaled PCO 2 levels, vital signs, and individual tolerance did not significantly differ between the two models. Conclusions : The findings suggest that CPAP-AirFlife™ is a practical and cost-effective alternative for non-invasive ventilatory support. Its technological advantages, including the aerosol-controlled helmet, make it suitable for high-risk environments. The device's accessibility and affordability make it a promising solution for implementation in low-level hospitals, particularly in rural areas. This study supports using CPAP-AirFlife™ as a practical option for non-invasive ventilatory support, providing a valuable contribution to respiratory care during the COVID-19 pandemic and beyond.