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.
ObjectiveTo study the feasibility of automated titration of oxygen therapy in the delivery room for preterm infants.DesignProspective non-randomised study of oxygenation in sequential preterm cohorts in which FiO2 was adjusted manually or by an automated control algorithm during the first 10 min of life.SettingDelivery rooms of a tertiary level hospital.ParticipantsPreterm infants <32 weeks gestation (n=20 per group).InterventionAutomated oxygen control using a purpose-built device, with SpO2 readings input to a proportional-integral-derivative algorithm, and FiO2 alterations actuated by a motorised blender. The algorithm was developed via in silico simulation using abstracted oxygenation data from the manual control group. For both groups, the SpO2 target was the 25th–75th centile of the Dawson nomogram.Main outcome measuresProportion of time in the SpO2 target range (25th–75th centile, or above if in room air) and other SpO2 ranges; FiO2 adjustment frequency; oxygen exposure.ResultsTime in the SpO2 target range was similar between groups (manual control: median 60% (IQR 48%–72%); automated control: 70 (60–84)%; p=0.31), whereas time with SpO2 >75th centile when receiving oxygen differed (manual: 17 (7.6–26)%; automated: 10 (4.4–13)%; p=0.048). Algorithm-directed FiO2 adjustments were frequent during automated control, but no manual adjustments were required in any infant once valid SpO2 values were available. Oxygen exposure was greater during automated control, but final FiO2 was equivalent.ConclusionAutomated oxygen titration using a purpose-built algorithm is feasible for delivery room management of preterm infants, and warrants further evaluation.
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