The SafeBoosC phase II clinical trial: an analysis of the interventions related with the oximeter readings

BACKGROUND: The SafeBoosC phase II randomised clinical trial recently demonstrated the benefits of a combination of cerebral regional tissue oxygen saturation (rStO(2)) by near-infrared spectroscopy (NIRS) and a treatment guideline to reduce the oxygen imbalance in extremely preterm infants. AIMS: To analyse rStO(2)-alarm-related clinical decisions and their heterogeneity in the NIRS experimental group (NIRS monitoring visible) and their impact on rStO(2) and SpO(2). METHODS: Continuous data from NIRS devices and the alarms (area under the curve of the rStO(2) out of range had accumulated 0.2%h during 10 min), clinical data at discrete time points and interventions prompted by the alarms were recorded. RESULTS: Sixty-seven infants had data that fulfilled the requirements for this analysis. 1107 alarm episodes were analysed. The alarm triggered a treatment guideline intervention in 25% of the cases; the type of intervention chosen varied among clinical sites. More than 55% of alarms were not followed by an intervention (‘No action’); additionally, in 5% of alarms the rStO(2) value apparently was considered non-reliable and the sensor was repositioned. The percentage of unresolved alarms at 30 min after ‘No action’ almost doubled the treatment guideline intervention (p<0.001). Changes in peripheral oxygen saturation (SpO(2)), were observed only after treatment guideline interventions. CONCLUSIONS: This study shows that 25% of rStO(2) alarms were followed by a clinical intervention determined by the treatment guideline. However, the rStO(2) and SpO(2) returned to normal ranges after the intervention, supporting the notion that decisions taken by the clinicians were appropriate. TRIAL REGISTRATION NUMBER: ClinicalTrial.gov NCT01590316.