Assessing the safety and efficacy of XVENT™ CMV20 Frontliner ventilation: A feasibility study of CPAP and BiPAP modes

Background: Non-invasive ventilation (NIV), including continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP), is essential in managing acute respiratory failure (ARF). The XVENT™ CMV20 Frontliner is a locally developed, dual-mode NIV device tailored for resource-limited settings. This study evaluated its performance and patient tolerance in CPAP and BiPAP modes. Methods: In this single-center, randomized, equivalence trial (July–October 2020), adult patients with acute hypoxemic respiratory failure (SpO₂ <93%, respiratory rate >28/min) and no risk of hypercapnia were randomly assigned (1:1) to receive either CPAP or BiPAP via XVENT™. Outcomes included oxygen saturation, respiratory rate, blood pressure, heart rate, and comfort over 54 hours. Results: Twenty patients were enrolled. Both CPAP and BiPAP significantly improved SpO₂ (>95%) within 3 hours (P < 0.0001), with concurrent reductions in respiratory rate, heart rate, and blood pressure. No significant differences were found between groups in these physiological parameters. However, comfort scores improved more in the CPAP group (P = 0.0006). The device operated stably, delivering consistent pressures with minor, non-clinically significant deviations from set values. Conclusion: The XVENT™ CMV20 Frontliner effectively delivers CPAP and BiPAP therapy in ARF. Both modes improved oxygenation and reduced respiratory distress. CPAP was better tolerated, suggesting it may be the preferred mode in hypoxemic patients without hypercapnia, especially in resource-limited settings. Clinical Trial Registry: ISRCTN68812324