2.3. Clinical Trial Design
To ascertain the clinical efficacy of the device, a rigorous randomized non-inferiority and randomized crossover clinical trial was conducted at Servicios Especiales de Salud (S.E.S) Hospital Universitario de Caldas, situated in Manizales, Caldas, Colombia. The testing procedures took place within a specially adapted hospital environment to cater to COVID-19 patients. For comparative analysis of ventilation technologies, the S.E.S Hospital Universitario de Caldas provided the General Electric ventilator model R860 alongside the CPAP-AirFlife™ system.