Objective To compare the effect of two different automated oxygen control devices on target range (TR) time and occurrence of hypoxaemic and hyperoxaemic episodes. Design Randomised cross-over study. Setting Tertiary level neonatal unit in the Netherlands. Patients Preterm infants (n=15) born between 24+0 and 29+6 days of gestation, receiving invasive or non-invasive respiratory support with oxygen saturation (SpO2) TR of 91%–95%. Median gestational age 26 weeks and 4 days (IQR 25 weeks 3 days–27 weeks 6 days) and postnatal age 19 (IQR 17–24) days. Interventions Inspired oxygen concentration was titrated by the OxyGenie controller (SLE6000 ventilator) and the CLiO2 controller (AVEA ventilator) for 24 hours each, in a random sequence, with the respiratory support mode kept constant. Main outcome measures Time spent within set SpO2 TR (91%–95% with supplemental oxygen and 91%–100% without supplemental oxygen). Results Time spent within the SpO2 TR was higher during OxyGenie control (80.2 (72.6–82.4)% vs 68.5 (56.7–79.3)%, p<0.005). Less time was spent above TR while in supplemental oxygen (6.3 (5.1–9.9)% vs 15.9 (11.5–30.7)%, p<0.005) but more time spent below TR during OxyGenie control (14.7 (11.8%–17.2%) vs 9.3 (8.2–12.6)%, p<0.05). There was no significant difference in time with SpO2 <80% (0.5 (0.1–1.0)% vs 0.2 (0.1–0.4)%, p=0.061). Long-lasting SpO2 deviations occurred less frequently during OxyGenie control. Conclusions The OxyGenie control algorithm was more effective in keeping the oxygen saturation within TR and preventing hyperoxaemia and equally effective in preventing hypoxaemia (SpO2 <80%), although at the cost of a small increase in mild hypoxaemia. Trial registry number [NCT03877198][1] Data are available on reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03877198&atom=%2Ffetalneonatal%2Fearly%2F2021%2F06%2F09%2Farchdischild-2020-321387.atom

中文翻译：

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两种早产儿自动氧气控制装置的比较：一项随机交叉试验

目的比较两种不同的自动氧气控制装置对目标范围（TR）时间和低氧血症和高氧血症发作的影响。设计随机交叉研究。在荷兰设置三级新生儿病房。患者 早产儿 (n=15) 在妊娠 24+0 至 29+6 天之间出生，接受有创或无创呼吸支持，氧饱和度 (SpO2) TR 为 91%–95%。中位胎龄 26 周零 4 天（IQR 25 周 3 天-27 周 6 天）和产后年龄 19（IQR 17-24）天。干预措施 吸入氧浓度由 OxyGenie 控制器（SLE6000 呼吸机）和 CLiO2 控制器（AVEA 呼吸机）按随机顺序分别滴定 24 小时，呼吸支持模式保持恒定。主要结果测量在设定的 SpO2 TR 内花费的时间（91%–95% 有补充氧气，91%–100% 没有补充氧气）。结果 OxyGenie 控制期间 SpO2 TR 内花费的时间更长（80.2 (72.6–82.4)% 与 68.5 (56.7–79.3)%，p<0.005）。在补充氧气中花费在 TR 以上的时间更少（6.3 (5.1–9.9)% vs 15.9 (11.5–30.7)%, p<0.005），但在 OxyGenie 控制期间花费在 TR 以下的时间更多（14.7 (11.8%–17.2%) vs 9.3 (8.2–12.6)%，p<0.05)。SpO2 <80% 的时间没有显着差异（0.5 (0.1–1.0)% vs 0.2 (0.1–0.4)%，p=0.061）。在 OxyGenie 控制期间，发生长期 SpO2 偏差的频率较低。结论 OxyGenie 控制算法在保持 TR 内的氧饱和度和预防高氧血症方面更有效，在预防低氧血症（SpO2 <80%）方面同样有效，尽管以轻度低氧血症的小幅增加为代价。试验注册号 [NCT03877198][1] 可根据合理要求提供数据。[1]：/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03877198&atom=%2Ffetalneonatal%2Fearly%2F2021%2F06%2F09%2Farchdischild-2020-321387.atom