Randomised crossover trial comparing algorithms and averaging times for automatic oxygen control in preterm infants.

OBJECTIVE

Automatic control (SPOC) of the fraction of inspired oxygen (FiO), based on continuous analysis of pulse oximeter saturation (SpO), improves the proportion of time preterm infants spend within a specified SpO-target range (Target%). We evaluated if a revised SPOC algorithm (SPOC, including an upper limit for FiO) compared to both routine manual control (RMC) and the previously tested algorithm (SPOC unrestricted maximum FiO) increases Target%, and evaluated the effect of the pulse oximeter's averaging time on controlling the SpO signal during SPOC periods.

DESIGN

Unblinded, randomised controlled crossover study comparing 2 SPOC algorithms and 2 SpO averaging times in random order: 12 hours SPOC and 12 hours SPOC (averaging time 2 s or 8 s for 6 hours each) were compared with 6-hour RMC. A generated list of random numbers was used for allocation sequence.

SETTING

University-affiliated tertiary neonatal intensive care unit, Germany PATIENTS: Twenty-four infants on non-invasive respiratory support with FiO >0.21 were analysed (median gestational age at birth, birth weight and age at randomisation were 25.3 weeks, 585 g and 30 days).

MAIN OUTCOME MEASURE

Target%.

RESULTS

Mean (SD) [95% CI] Target% was 56% (9) [52, 59] for RMC versus 69% (9) [65, 72] for SPOC_, 70% (7) [67, 73] for SPOC_, 71% (8) [68, 74] for SPOC_ and 72% (8) [69, 75] for SPOC_.

CONCLUSIONS

Irrespective of SpO-averaging time, Target% was higher with both SPOC algorithms compared to RMC. Despite limiting the maximum FiO, SPOC remained significantly better at maintaining SpO within target range compared to RMC.

TRIAL REGISTRATION

NCT03785899.