Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial

ObjectiveTo compare the effect of two different automated oxygen control devices on target range (TR) time and occurrence of hypoxaemic and hyperoxaemic episodes.DesignRandomised cross-over study.SettingTertiary level neonatal unit in the Netherlands.PatientsPreterm 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.InterventionsInspired 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 measuresTime spent within set SpO2 TR (91%–95% with supplemental oxygen and 91%–100% without supplemental oxygen).ResultsTime 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.ConclusionsThe 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 numberNCT03877198

Automated control of oxygen titration in preterm infants on non-invasive respiratory support

ObjectiveTo evaluate the performance of a rapidly responsive adaptive algorithm (VDL1.1) for automated oxygen control in preterm infants with respiratory insufficiency.DesignInterventional cross-over study of a 24-hour period of automated oxygen control compared with aggregated data from two flanking periods of manual control (12 hours each).SettingNeonatal intensive care unit.ParticipantsPreterm infants receiving non-invasive respiratory support and supplemental oxygen; median birth gestation 27 weeks (IQR 26–28) and postnatal age 17 (12–23) days.InterventionAutomated oxygen titration with the VDL1.1 algorithm, with the incoming SpO2 signal derived from a standard oximetry probe, and the computed inspired oxygen concentration (FiO2) adjustments actuated by a motorised blender. The desired SpO2 range was 90%–94%, with bedside clinicians able to make corrective manual FiO2 adjustments at all times.Main outcome measuresTarget range (TR) time (SpO2 90%–94% or 90%–100% if in air), periods of SpO2 deviation, number of manual FiO2 adjustments and oxygen requirement were compared between automated and manual control periods.ResultsIn 60 cross-over studies in 35 infants, automated oxygen titration resulted in greater TR time (manual 58 (51–64)% vs automated 81 (72–85)%, p<0.001), less time at both extremes of oxygenation and considerably fewer prolonged hypoxaemic and hyperoxaemic episodes. The algorithm functioned effectively in every infant. Manual FiO2 adjustments were infrequent during automated control (0.11 adjustments/hour), and oxygen requirements were similar (manual 28 (25–32)% and automated 26 (24–32)%, p=0.13).ConclusionThe VDL1.1 algorithm was safe and effective in SpO2 targeting in preterm infants on non-invasive respiratory support.Trial registration numberACTRN12616000300471.

The effect of automated oxygen control on clinical outcomes in preterm infants: a pre- and post-implementation cohort study

Several studies demonstrated an increase in time spent within target range when automated oxygen control (AOC) is used. However the effect on clinical outcome remains unclear. We compared clinical outcomes of preterm infants born before and after implementation of AOC as standard of care. In a retrospective pre-post implementation cohort study of outcomes for infants of 24–29 weeks gestational age receiving respiratory support before (2012–2015) and after (2015–2018) implementation of AOC as standard of care were compared. Outcomes of interest were mortality and complications of prematurity, number of ventilation days, and length of stay in the Neonatal Intensive Care Unit (NICU). A total of 588 infants were included (293 pre- vs 295 in the post-implementation cohort), with similar gestational age (27.8 weeks pre- vs 27.6 weeks post-implementation), birth weight (1033 grams vs 1035 grams) and other baseline characteristics. Mortality and rate of prematurity complications were not different between the groups. Length of stay in NICU was not different, but duration of invasive ventilation was shorter in infants who received AOC (6.4 ± 10.1 vs 4.7 ± 8.3, p = 0.029).Conclusion: In this pre-post comparison, the implementation of AOC did not lead to a change in mortality or morbidity during admission. What is Known:• Prolonged and intermittent oxygen saturation deviations are associated with mortality and prematurity-related morbidities.• Automated oxygen controllers can increase the time spent within oxygen saturation target range.What is New:• Implementation of automated oxygen control as standard of care did not lead to a change in mortality or morbidity during admission.• In the period after implementation of automated oxygen control, there was a shift toward more non-invasive ventilation.

Automated oxygen control in preterm infants, how does it work and what to expect: a narrative review

BackgroundAutomated oxygen control systems are finding their way into contemporary ventilators for preterm infants, each with its own algorithm, strategy and effect.ObjectiveTo provide guidance to clinicians seeking to comprehend automated oxygen control and possibly introduce this technology in their practice.MethodA narrative review of the commercially available devices using different algorithms incorporating rule-based, proportional-integral-derivative and adaptive concepts are described and explained. An overview of how they work and, if available, the clinical effect is given.ResultsAll algorithms have shown a beneficial effect on the proportion of time that oxygen saturation is within target range, and a decrease in hyperoxia and severe hypoxia. Automated oxygen control may also reduce the workload for bedside staff. There is concern that such devices could mask clinical deterioration, however this has not been reported to date.ConclusionsSo far, trials involving different algorithms are heterogenous in design and no head-to-head comparisons have been made, making it difficult to differentiate which algorithm is most effective and what clinicians can expect from algorithms under certain conditions.