Automatic oxygen control for reducing extremes of oxygen saturation: a randomised controlled trial

Abstract

Objective The objective of this study was to evaluate the efficacy of the automatic oxygen control (A-Fio 2 ) in reducing the percentage of time spent in severe hypoxaemia (Spo 2 <80%) in preterm infants for the time period on invasive ventilation and/or nasal continuous positive airway pressure (NCPAP) delivered by AVEA ventilator. Design A parallel arm randomised controlled trial. Setting A level-III neonatal intensive care unit. Patients Preterm infants (<33 weeks birth gestation) who received invasive ventilation or NCPAP in the first 72 hours of age. Interventions A-Fio 2 vs manual (M-Fio 2 ) oxygen control. Outcomes The primary outcome of the study was percentage of time spent in severe hypoxaemia (Spo 2 <80%). Results 44 infants were randomised to either A-Fio 2 or M-Fio 2 arm and continued in the study for the period of respiratory support (invasive ventilation and/or NCPAP). The total number of study days in A-Fio2 and M-Fio 2 arm were 194 and 204 days, respectively. The percentage of time spent in Spo 2 <80% was significantly lower with A-Fio 2 compared with M-Fio 2 (median of 0.1% (IQR: 0.07–0.7) vs 0.6% (0.2–2); p=0.03). The number of prolonged episodes (>60 s) of Spo 2 <80% per day was also significantly lower in A-Fio 2 (0.3 (0.0–2) vs 2 (0.6–6); p=0.02). Conclusion A-Fio 2 was associated with statistically significant reduction in the percentage of time spent in severe hypoxaemia when compared with M-Fio 2 in preterm infants receiving respiratory support. Trial registration number NCT04223258 .