Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunokicho, Chuo-Ku, Kobe, Hyogo, Japan.
Clinical and Translational Research Center, Kobe University Hospital, 7-5-2 Kusunokicho, Chuo-Ku, Kobe, Hyogo, Japan.
Sci Rep. 2024 Sep 3;14(1):20505. doi: 10.1038/s41598-024-71320-7.
The newly developed portable oxygen concentrator with an auto-demand oxygen delivery system (auto-DODS) automatically switches between 3 sensitivities according to the negative pressure gradient of inhalation and supplies oxygen only during inhalation. The aim of this study was to verify the effectiveness and safety of auto-demand devices compared with a continuous flow oxygen concentrator, during sleep, in a randomized crossover noninferiority trial. We alternatively used an auto-DODS or a continuous-flow oxygen concentrator, all night on separate days for HOT (Home Oxygen Therapy) patients with nocturnal hypoxemic symptoms. The primary endpoints were the mean value of oxygen saturation (SpO) over the total sleep time. The secondary endpoints included the efficacy endpoints and the safety endpoints. Regarding the primary endpoint, the difference in SpO between the auto-DODS and continuous flow was 0.835%. Since the upper limit of this difference did not exceed 2.8, which was set as the noninferiority margin, it was shown that the auto-DODS did not reduce SpO by at least 2.8% on average compared to continuous flow. No equipment failure or exacerbation of disease was observed, confirming the safety of the auto-DODS during the night.
新开发的带有自动按需供氧系统（auto-DODS）的便携式氧气浓缩器会根据吸气负压梯度自动在 3 种灵敏度之间切换，仅在吸气时提供氧气。本研究旨在通过随机交叉非劣效性试验，验证自动按需供氧设备在睡眠期间与连续流量氧气浓缩器相比的有效性和安全性。我们在不同的日子里，交替使用自动-DODS 或连续流量氧气浓缩器，为有夜间低氧血症症状的 HOT（家庭氧疗）患者提供整夜治疗。主要终点是总睡眠时间内的平均血氧饱和度（SpO）值。次要终点包括疗效终点和安全性终点。关于主要终点，SpO 在自动-DODS 和连续流量之间的差异为 0.835%。由于该差异的上限不超过 2.8，这是设定的非劣效性界限，因此表明与连续流量相比，自动-DODS 不会使 SpO 平均至少降低 2.8%。在夜间，未观察到设备故障或疾病恶化，证实了自动-DODS 的安全性。
