Introduction When children require supplemental oxygen due to acute hypoxemic respiratory distress (AHRD), manual control of the oxygen flow is often difficult and time-consuming, and carries the risk of unrecognized hypoxia and hyperoxia. To date, no automatic oxygen titration system has been developed and evaluated in spontaneously breathing children. Methods Children between 1 month and 15 years of age receiving supplemental oxygen due to AHRD were recruited within 24 hours following the onset of the O(2)administration in a French University Department of Paediatrics. Patients were randomized to receive either automated oxygen administration using the FreeO2 device, or conventional manual oxygen administration over a maximum period of 6 hours. Stratification was performed to classify the patients into two age groups: 1 month to 2 years of age and 2 to 15 years of age. The primary outcome was % time spent within the SpO(2)target range (92%-98%). Results 60 patients (30 infants, 30 children) were randomized and 55 could be analyzed for the primary outcome (28 automated, 27 manual). The automated O(2)delivery using the FreeO2 device significantly increased the time spent within the predefined SpO(2)range (94.6% +/- 6% vs 76.3% +/- 22%, difference [95% confidence interval {CI}] 18.4 [10.1; 26.7]) with less time spent with hypoxemia (1% +/- 1.1% vs 15.1% +/- 21.8%, difference [95% CI] -14.4 [-22.2; -6.7]). This difference was greater among (2-15 years of age) children, compared to (1 month-2 years of age) infants. Conclusions The present randomized controlled pilot study indicates that the tested automated closed-loop O(2)titration technology was safe and yielded improved oxygen parameters among spontaneously breathing children. Based on our pilot data, a full randomized controlled trial will be required to verify the potential clinical benefits.
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