Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial
Salverda,Hylke H Cramer,Sophie J E Witlox,Ruben S G M Gale,Timothy J Dargaville,Peter A Pauws,Steffen C Te Pas,Arjan B
Salverda,Hylke H
Cramer,Sophie J E
Witlox,Ruben S G M
Gale,Timothy J
Dargaville,Peter A
Pauws,Steffen C
Te Pas,Arjan B
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.
Description
Funding Information: This work was supported by SLE Limited by an unrestricted research grant. Publisher Copyright: © 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.
Date
2022-01-01
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Keywords
Algorithms, Cross-Over Studies, Humans, Hypoxia/etiology, Infant, Newborn, Infant, Premature, Oxygen Saturation, Respiration, Artificial/adverse effects, Respiratory Distress Syndrome, Newborn/blood, Ventilators, Mechanical
Citation
Salverda, H H, Cramer, S J E, Witlox, R S G M, Gale, T J, Dargaville, P A, Pauws, S C & Te Pas, A B 2022, 'Comparison of two devices for automated oxygen control in preterm infants : a randomised crossover trial', Archives of Disease in Childhood. Fetal and Neonatal Edition, vol. 107, no. 1, pp. F20-F25. https://doi.org/10.1136/archdischild-2020-321387
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info:eu-repo/semantics/openAccess