Experimental validation of a novel portable device integrating an oxygen concentrator and a ventilation module for patients with ALI/ARDS in low resource countries: a cross-over non-inferiority trial

Background: This non-inferiority, cross-over study aims to evaluate a novel proof-of-concept portable respiratory support device specifically designed for low-resource settings. The device integrates a ventilation module and an oxygen concentrator. Methods: We studied twelve 4-week-old piglets with a mean weight of 8.4 kg before and after oleic acid-induced acute respiratory distress syndrome (ARDS). In each condition, animals received 1-h pressure control ventilation using a conventional ventilator (Servo-i, Getinge, SE) and the experimental ventilator in random sequence. Arterial blood gas analysis was performed every half-hour to adjust the ventilator settings. The primary outcome was partial pressure of oxygen to FiO2 ratio (P/F) with a non-inferiority margin of 50 mmHg. Results: P/F did not differ significantly between the experimental and the control ventilation at baseline (459.6(30.9) vs 454.4(28.6) mmHg) and during ARDS condition (165.1(36.9) vs 182.5(48.4) mmHg). The upper 95% CI of the difference between P/F after ventilation using the control and the experimental ventilator was 37.3 and 44.1 mmHg during baseline and ARDS, respectively. Conclusions: The experimental device was not inferior to a conventional ventilator during both baseline and ARDS conditions, suggesting that it can provide adequate treatment to infants with mild to moderate hypoxemic lung disease in resource-limited care settings. Impact statement: This manuscript provides the results of a non-inferiority study that compared a novel proof-of-concept respiratory support device, integrating a ventilation module and an oxygen concentrator, specifically designed for respiratory support in low-resource settings, with a conventional pediatric intensive care ventilator in an oleic-acid model of acute lung injury. Our results showed that the experimental device was non-inferior to a conventional ventilator, suggesting that it can provide adequate treatment to infants with mild to moderate hypoxemic lung disease in resource-limited care settings. The developed solution can also be relevant for other applications, including home mechanical ventilation.