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

Hylke H Salverda, Sophie J E Cramer, Ruben S G M Witlox, Timothy J Gale, Peter A Dargaville, Steffen C Pauws, Arjan B Te Pas, Hylke H Salverda, Sophie J E Cramer, Ruben S G M Witlox, Timothy J Gale, Peter A Dargaville, Steffen C Pauws, Arjan B Te Pas

Abstract

Objective: To compare the effect of two different automated oxygen control devices on target range (TR) time and occurrence of hypoxaemic and hyperoxaemic episodes.

Design: Randomised cross-over study.

Setting: Tertiary level neonatal unit in the Netherlands.

Patients: Preterm 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.

Interventions: Inspired 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 measures: Time spent within set SpO2 TR (91%-95% with supplemental oxygen and 91%-100% without supplemental oxygen).

Results: Time 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.

Conclusions: The 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 number: NCT03877198.

Keywords: neonatology; technology.

Conflict of interest statement

Competing interests: ABtP has received an unrestricted research grant from SLE Limited; they had no role in study design nor in the collection, analysis, and interpretation of data, writing of the report and decision to submit the paper for publication. The University of Tasmania and Royal Hobart Hospital have a patent concerning automated control of inspired oxygen concentration in the new-born infant and have a licensing agreement with SLE Limited in relation to OxyGenie automated oxygen control software.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
CONSORT flow diagram.
Figure 2
Figure 2
SpO2 histograms. Pooled time spent per SpO2 value as proportion of total usable time, while receiving supplemental oxygen and ambient air (total) or while only receiving supplemental oxygen. Dashed lines represent the limits of the SpO2 target range.
Figure 3
Figure 3
Comparison of OxyGenie control with CLiO2 control. Individual paired values of proportion of time within TR while on OxyGenie control and while on CLiO2 control. Horizontal bar=median. Within TR=91%–95% with supplemental oxygen or 91%–100% without supplemental oxygen. TR, target range.

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