A new portable and ready-to-use device for out-of-hospital non-invasive treatment of acute respiratory failure: preclinical validation

Background: Acute respiratory failure (ARF) remains a leading cause of emergency medical intervention and requires prompt management to prevent severe morbidity and mortality. Non-invasive ventilatory (NIV) support in the pre-hospital setting via Continuous Positive Airway Pressure (CPAP) can improve ARF outcomes. However, existing CPAP devices demand specialized technical expertise and require complex setup, thereby presenting usability barriers in emergency out-of-hospital scenarios. Aim of this study was to develop, and preclinically validate, a portable, ready-to-use CPAP device specifically designed for out-of-hospital emergency treatment of ARF. Methods: The device performance, efficacy and safety profile were evaluated using a high-fidelity lung simulator replicating various ARF conditions at different respiratory requirements. Positive End-Expiratory Pressure (PEEP) levels were monitored. Afterwards, usability was assessed by 15 operators of varying medical expertise, who applied the device on a manikin connected to the simulator. Results: In preclinical validation tests the device demonstrated reliable performance, consistently stabilizing PEEP around the target value of 5 cmH2O across all simulated scenarios. In usability tests, 93% of operators successfully applied the device, achieving the target PEEP in the simulated manikin setting. The operators’ feedback highlighted that the device provides respiratory support in a compact and user-friendly format and is of rapid and intuitive application with minimum effort. All operators expressed their willingness to use the device during real emergency situations. Conclusions: Our new CPAP device showed promise in preclinical simulation-based tests as a tool for improving pre-hospital emergency response to ARF, enabling timely, effective and safe respiratory support during critical early phases. Validation tests in humans are ongoing.