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

Arch Dis Child Fetal Neonatal Ed. 2023 Mar;108(2):136-141. doi: 10.1136/archdischild-2022-324160. Epub 2022 Aug 23.

Abstract

Objective: The objective of this study was to evaluate the efficacy of the automatic oxygen control (A-Fio2) in reducing the percentage of time spent in severe hypoxaemia (Spo2 <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-Fio2 vs manual (M-Fio2) oxygen control.

Outcomes: The primary outcome of the study was percentage of time spent in severe hypoxaemia (Spo2 <80%).

Results: 44 infants were randomised to either A-Fio2 or M-Fio2 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-Fio2 arm were 194 and 204 days, respectively. The percentage of time spent in Spo2 <80% was significantly lower with A-Fio2 compared with M-Fio2 (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 Spo2 <80% per day was also significantly lower in A-Fio2 (0.3 (0.0-2) vs 2 (0.6-6); p=0.02).

Conclusion: A-Fio2 was associated with statistically significant reduction in the percentage of time spent in severe hypoxaemia when compared with M-Fio2 in preterm infants receiving respiratory support.

Trial registration number: NCT04223258.

Keywords: Intensive Care Units, Neonatal; Neonatology.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Continuous Positive Airway Pressure
  • Humans
  • Hypoxia / prevention & control
  • Infant, Newborn
  • Infant, Premature*
  • Oxygen Saturation
  • Oxygen*

Substances

  • Oxygen

Associated data

  • ClinicalTrials.gov/NCT04223258