WHAT'S KNOWN ON THIS SUBJECT: In preterm infants receiving supplemental oxygen, manual control of the inspired oxygen fraction is often difficult and time consuming, which may increase the risk of complications. We developed a system for automatic oxygen control and proved its efficacy in the past.
WHAT THIS STUDY ADDS:A multicenter study adds evidence for the proposed automatic oxygen control system to significantly improve oxygen administration to preterm infants receiving mechanical ventilation or nasal continuous positive airway pressure while reducing workload compared with routine manual oxygen control. abstract BACKGROUND AND OBJECTIVE: In preterm infants receiving supplemental oxygen, routine manual control (RMC) of the fraction of inspired oxygen (FIO 2 ) is often difficult and time consuming. We developed a system for closed-loop automatic control (CLAC) of the FIO 2 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.
METHODS: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.
RESULTS: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 FIO 2 adjustments was reduced from 77.0 (0.0-224.0) for RMC to 52.0 (10.0-317.0) for CLAC (P = .007).CONCLUSIONS: CLAC may improve oxygen administration to preterm infants receiving mechanical ventilation or nasal continuous positive airway pressure while reducing workload related to RMC. Pediatrics 2014;133:e379-e385 Preterm infants frequently require supplemental oxygen (O 2 ). The goal of this therapy is to deliver sufficient O 2 to the tissues while minimizing O 2 toxicity and oxidative stress, which may result from too high or too widely fluctuating O 2 levels. Although the optimal level of arterial pulse oximeter saturation (SpO 2 ) is still debated, there is evidence that wide fluctuations in SpO 2 should in any case be avoided. [1][2][3] This may be difficult to achieve, however, under routine clinical conditions. 4 Thus, automatic titration of the fraction of inspired oxygen (FIO 2 ) by using a closedloop FIO 2 controller (FIO 2 C) seems attractive. The first attempts at automating O 2 delivery to patients date back to the 1970s, but only recently, with the advance of motion-resistant pulse oximetry, sophisticated systems have been developed that seem to be suitable for clinical use in preterm infants requiring respiratory support. 5,6 In a group of preterm infants receiving nasal continuous posit...