Poletto Sofia, Diaper John, Montanarini Aurora, Merighi Giovanni, Fontao Fabienne, Belin Xavier, Zannin Emanuela, Habre Walid, Dellacà Raffaele L
Techres Lab, Dipartimento di Elettronica, Informazione e Bioingegneria-DEIB, Politecnico di Milano University, Milano, Italy.
Department of Anesthesiology, Pharmacology, Intensive Care and Emergency Medicine, University of Geneva, Geneva, Switzerland.
Pediatr Res. 2025 Feb 4. doi: 10.1038/s41390-024-03792-2.
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.
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 FiO ratio (P/F) with a non-inferiority margin of 50 mmHg.
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.
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.
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.
这项非劣效性交叉研究旨在评估一种专门为资源匮乏地区设计的新型概念验证便携式呼吸支持设备。该设备集成了一个通气模块和一个制氧机。
我们研究了12只4周龄、平均体重8.4千克的仔猪，观察油酸诱导的急性呼吸窘迫综合征（ARDS）前后的情况。在每种情况下，动物随机顺序接受使用传统呼吸机（Servo-i，Getinge，瑞典）和实验呼吸机进行的1小时压力控制通气。每半小时进行一次动脉血气分析以调整呼吸机设置。主要结局是氧分压与吸入氧分数比（P/F），非劣效性界值为50 mmHg。
在基线时（459.6(30.9) vs 454.4(28.6) mmHg）以及ARDS状态下（165.1(36.9) vs 182.5(48.4) mmHg），实验通气和对照通气之间的P/F无显著差异。在基线和ARDS期间，使用对照呼吸机和实验呼吸机通气后P/F差异的95%置信区间上限分别为37.3和44.1 mmHg。
在基线和ARDS状态下，实验设备均不劣于传统呼吸机，这表明它可以在资源有限的护理环境中为轻度至中度低氧性肺病婴儿提供充分治疗。
本手稿提供了一项非劣效性研究的结果，该研究在油酸诱导的急性肺损伤模型中，将一种集成通气模块和制氧机、专门为资源匮乏地区呼吸支持设计的新型概念验证呼吸支持设备与传统儿科重症监护呼吸机进行了比较。我们的结果表明，实验设备不劣于传统呼吸机，这表明它可以在资源有限的护理环境中为轻度至中度低氧性肺病婴儿提供充分治疗。所开发的解决方案也可能与其他应用相关，包括家庭机械通气。
