Is faster better? A randomised crossover study comparing algorithms for closed-loop automatic oxygen control. Issue 4 (16th September 2019)

• Record Type: Journal Article
• Authors: Schwarz, Christoph E; Kidszun, André; Bieder, Nicole S; Franz, Axel R; König, Jochem; Mildenberger, Eva; Poets, Christian F; Seyfang, Andreas; Urschitz, Michael S
• Is Part Of: Archives of disease in childhood. Volume 105:Issue 4(2020)
• Page Start: 369
• Page End: 374
• Publication Date: 2019-09-16
• Subjects: Neonatology -- Respiratory -- controller -- ventilation -- hypoxia; Infants -- Diseases -- Periodicals; Newborn infants -- Diseases -- Periodicals; Fetus -- Diseases -- Periodicals; 618.920105
• DOI: 10.1136/archdischild-2019-317029
• Languages: English
• ISSNs: 1359-2998

Abstract

Abstract : Objective: Closed-loop automatic control (CLAC) of the fractional inspired oxygen (FiO2 ) improved oxygen administration to preterm infants on respiratory support. We investigated whether a revised CLAC algorithm (CLACfast, ≤2 FiO2 adjustments/min), compared with routine manual control (RMConly ), increased the proportion of time with arterial haemoglobin oxygen saturation measured by pulse oximetry within prespecified target ranges (Target%) while not being inferior to the original algorithm (CLACslow : ≤0.3 FiO2 adjustments/min). Design: Unblinded randomised controlled crossover study comparing three modes of FiO2 control in random order for 8 hours each: RMC supported by CLACfast was compared with RMConly and RMC supported by CLACslow . A computer-generated list of random numbers using a block size of six was used for the allocation sequence. Setting: Two German tertiary university neonatal intensive care units. Patients: Of 23 randomised patients, 19 were analysed (mean±SD gestational age 27±2 weeks; age at randomisation 24±10 days) on non-invasive (n=18) or invasive (n=1) respiratory support at FiO2 >0.21. Main outcome measure: Target%. Results: Mean±SD [95% CI] Target% was 68%±11% [65% to 71%] for CLACfast versus 65%±11% [61% to 68%] for CLACslow versus 58%±11% [55% to 62%] for RMConly . Prespecified hypothesis tests of: (A) superiority of CLACfast versus RMConly and (B) non-inferiority of CLACfast versus CLACslow with margin of 5% yielded one-sided p values of <0.001 for both comparisons. Conclusions: This revised and faster CLAC algorithm was still superior to routine care in infants on respiratory support and not inferior to a previously tested slower algorithm. Trial registration number: NCT03163108 .