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Randomized Controlled Trial
. 2022 Jul;107(4):425-430.
doi: 10.1136/archdischild-2021-322096. Epub 2021 Nov 24.

Randomised crossover trial comparing algorithms and averaging times for automatic oxygen control in preterm infants

Christoph E Schwarz  1   2 , Karen B Kreutzer  3 , Lukas Langanky  1 , Nicole S Wolf  1 , Wolfgang Braun  4 , Marc Paul O'Sullivan  2   5 , Christian F Poets  1 , Axel R Franz  1   6
Affiliations
Randomized Controlled Trial

Randomised crossover trial comparing algorithms and averaging times for automatic oxygen control in preterm infants

Christoph E Schwarz et al. Arch Dis Child Fetal Neonatal Ed. 2022 Jul.

Abstract

Objective: Automatic control (SPOC) of the fraction of inspired oxygen (FiO2), based on continuous analysis of pulse oximeter saturation (SpO2), improves the proportion of time preterm infants spend within a specified SpO2-target range (Target%). We evaluated if a revised SPOC algorithm (SPOCnew, including an upper limit for FiO2) compared to both routine manual control (RMC) and the previously tested algorithm (SPOCold, unrestricted maximum FiO2) increases Target%, and evaluated the effect of the pulse oximeter's averaging time on controlling the SpO2 signal during SPOC periods.

Design: Unblinded, randomised controlled crossover study comparing 2 SPOC algorithms and 2 SpO2 averaging times in random order: 12 hours SPOCnew and 12 hours SPOCold (averaging time 2 s or 8 s for 6 hours each) were compared with 6-hour RMC. A generated list of random numbers was used for allocation sequence.

Setting: University-affiliated tertiary neonatal intensive care unit, Germany PATIENTS: Twenty-four infants on non-invasive respiratory support with FiO2 >0.21 were analysed (median gestational age at birth, birth weight and age at randomisation were 25.3 weeks, 585 g and 30 days).

Main outcome measure: Target%.

Results: Mean (SD) [95% CI] Target% was 56% (9) [52, 59] for RMC versus 69% (9) [65, 72] for SPOCold_2s, 70% (7) [67, 73] for SPOCnew_2s, 71% (8) [68, 74] for SPOCold_8s and 72% (8) [69, 75] for SPOCnew_8s.

Conclusions: Irrespective of SpO2-averaging time, Target% was higher with both SPOC algorithms compared to RMC. Despite limiting the maximum FiO2, SPOCnew remained significantly better at maintaining SpO2 within target range compared to RMC.

Trial registration: NCT03785899.

Keywords: neonatology; technology.

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Conflict of interest statement

Competing interests: The University of Tübingen holds a patent on the CLAC algorithm for automated oxygen control and have a licensing agreement with Löwenstein Medical in relation to this algorithm. ARF and CFP are supported by a grant from the German Ministry of Research and Education for conducting the FiO2 Controller study on medium-term effects of closed-loop automated control of FiO2. CES, ARF and CFP also received a research grant from Löwenstein Medical, Bad Ems, Germany. WB is an employee of Fritz Stephan GmbH. CFP received speaker honoraria from Masimo Inc. The other authors declare no competing interests.

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