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

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.

To compare the effect of two target ranges (91%-95% and 92%-96%) while on
automated oxygen control on the time spent under the target range in preterm
infants.

Randomised cross-over study.

In both groups supplemental oxygen will be titrated by the OxyGenie automated
oxygen controller for 25 hours, either titrated to a target range of 91%-95% or
92%-96%. Automated oxygen control aimed at a range of 91%-95% is standard of
care in our unit.

There is no additional burden for the patient as no extra interventions are
required.
A more stable SpO2 and fewer desaturations may reduce the risk of associated
morbidity. Considering the very short study period (25 hours on the
interventional target range), the behaviour of the oxygen controller while
within target range, and the unlikeliness of hyperoxaemia while on the upper
limit of the target range there are no additional risks of this study.
Preterm infants often need respiratory support and supplemental oxygen for a
prolonged period of time. Oxygen is often titrated in order to maintain SpO2
within the small therapeutic range. Both hypoxaemia and hyperoxaemia are
associated with morbidity and mortality in this group, and any intervention
aiming to reduce the risk therefore needs to be studied in this specific
population at risk.