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.