Optimising Oxygenation of Preterm infants during Respiratory support by fine-tuning Automatic TItration of Oxygen

A randomised crossover study comparing the effect of two oxygen saturation target ranges on time spent under the target range while preterm infants are on automated oxygen control. We will investigate whether

Hypoxia and hyperoxia during oxygen therapy for preterm infants can result in significant morbidity and mortality. To reduce these risks, continuous measurement of oxygen saturation (SpO2) guides the titration of supplemental oxygen to target SpO2 values of 91-95%. We have previously studied the effect of two automated oxygen controllers (the OxyGenie and the CLiO2) on time spent within a set target range in the COCkPIT trial. We showed a distinct difference in the distribution of oxygen saturation between controllers: the OxyGenie controller had a narrower distribution, with a significant reduction in time above target range when compared to the CLiO2 controller. However, this was accompanied by a disproportionally smaller increase in time spent under target range (15% during Oxygenie control, 9% during CLiO2 control). These differences may partly be explained by the tendency for the OxyGenie controller to target the midpoint of the target range (93% in case of a target range of 91%-95%). In contrast the CLiO2 controller, according to its patent, targets a SpO2 value of 94% while in target range. Considering the non-linearity of the oxygen tension and oxygen saturation relation (oxygen dissociation curve), it is possible that aiming for a higher target range while using automated oxygen titration will result in less time spent under the target range and fewer target range deviations.

We postulate that a set target range of 92%-96% will result in a more stable SpO2 and accompanying reduction of time spent with an SpO2 <91% and similar or less time >96% when compared to a target range of 91%-95%.

Outcome parameters (SpO2, FiO2, HR, frequency and duration of alarms) will continuously be monitored at a frequency of 1Hz by the standard bedside monitoring (Philips MP70) system throughout the two days of study participation.

Interventional target range: OxyGenie automated oxygen controller set to target an SpO2 of 92%-96% for 25 hours, including a 1 hour wash-out period after a change in set target range.
Standard target range: OxyGenie automated oxygen controller set to target an SpO2 of 91%-95% for 24 hours, excluding a 1 hour wash-out period after a change in set target range.