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Comparison of volume guarantee and volume-controlled ventilation both using closed loop inspired oxygen in preterm infants: a randomised crossover study (CLIO-VG study)

Objective The objective of this study was to compare two different modes of ventilation in maintaining oxygen saturation (SpO2) in target range (90%–95%) in ventilated preterm infants cared for with automatic control of oxygen delivery (A-FiO2). Design A single-centre randomised crossover study. Settings A level III neonatal intensive care unit. Patients Preterm infants receiving mechanical ventilation and oxygen requirement >21%. Interventions Volume guarantee (VG) vs volume controlled ventilation (VCV) modes with automatic oxygen control (A-FiO2). Outcomes The primary outcome of this study was the proportion of time spent with oxygen saturations in the target range (90%–95%) . Results Nineteen preterm infants with a median gestation age 25 weeks (IQR: 24–28) and birth weight 685 g (IQR: 595–980) were enrolled in the study. There was no significant difference in primary outcome of median proportion of time spent in target saturation between the two arms (72% (57–81) in VG vs 75% (58–83) in VCV; p=0.98). There was no significant difference in the secondary outcomes of time spent in SpO2 <80% (0.03% vs 0.14%; p=0.51), time spent in SpO2 >98% (0.50% vs 0.08%; p=0.54), the median FiO2 (31% vs 29%; p=0.51) or manual adjustments carried out between VG and VCV, respectively. The number of episodes of prolonged hypoxaemia and hyperoxaemia were similar in the two groups. Conclusion There was no significant difference in time spent in target SpO2 range between VG and VCV when A-FiO2 was used as the FiO2 controller in this crossover randomised control study. Trial registration number NCT03865069. Cross-over study addressing whether improved time within oxygen saturation target can be primarily improved by volume-controlled ventilation or automatic control of the FiO2, with the results clearly showing that the latter is more important for reaching this goal