Department of Neonatology, University Children's Hospital, Tuebingen, Germany;
Pediatrics. 2014 Feb;133(2):e379-85. doi: 10.1542/peds.2013-1834. Epub 2014 Jan 27.
In preterm infants receiving supplemental oxygen, routine manual control (RMC) of the fraction of inspired oxygen (FIO2) is often difficult and time consuming. We developed a system for closed-loop automatic control (CLAC) of the FIO2 and demonstrated its short-term safety and efficacy in a single-center study. The objective of this study was to test the hypothesis that this system is more effective than RMC alone in maintaining arterial oxygen saturation within target levels when evaluated over 24 hours under routine conditions and with different target levels.
We performed a multicenter, randomized controlled, crossover clinical trial in 34 preterm infants receiving mechanical ventilation or nasal continuous positive airway pressure and supplemental oxygen. Twenty-four-hour periods with RMC were compared with 24-hour periods of RMC supported by CLAC.
The median (range) percentage of time with arterial oxygen saturation levels within target range was 61.4 (31.5-99.5) for RMC and 71.2 (44.0-95.4) for CLAC (P < .001). The median (range) number of manual FIO2 adjustments was reduced from 77.0 (0.0-224.0) for RMC to 52.0 (10.0-317.0) for CLAC (P = .007).
CLAC may improve oxygen administration to preterm infants receiving mechanical ventilation or nasal continuous positive airway pressure while reducing workload related to RMC.
在接受补充氧气的早产儿中，常规手动控制（RMC）吸入氧分数（FIO2）通常既困难又耗时。我们开发了一种用于 FIO2 闭环自动控制（CLAC）的系统，并在一项单中心研究中证明了其短期安全性和有效性。本研究的目的是检验以下假设，即在常规条件下并使用不同的目标水平，与单独使用 RMC 相比，该系统在 24 小时内更有效地维持动脉血氧饱和度在目标水平。
我们对 34 名接受机械通气或鼻持续气道正压通气和补充氧气的早产儿进行了一项多中心、随机对照、交叉临床试验。将使用 RMC 的 24 小时时间段与由 CLAC 支持的 RMC 的 24 小时时间段进行比较。
RMC 时动脉血氧饱和度水平在目标范围内的中位数（范围）百分比为 61.4（31.5-99.5），CLAC 时为 71.2（44.0-95.4）（P<0.001）。RMC 时手动 FIO2 调整的中位数（范围）次数从 77.0（0.0-224.0）减少到 CLAC 时的 52.0（10.0-317.0）（P=0.007）。
CLAC 可以改善接受机械通气或鼻持续气道正压通气的早产儿的氧气输送，同时减少与 RMC 相关的工作量。
