The SafeBoosC phase II clinical trial: An analysis of the interventions related with the oximeter readings
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Published version
Date
2016-06-17
Authors
Riera, Joan
Hyttel-Sorensen, Simon
Bravo, María Carmen
Cabañas, Fernando
López-Ortego, Paloma
Sanchez, Laura
Ybarra, Marta
Dempsey, Eugene M.
Greisen, Gorm
Austin, Topun
Journal Title
Journal ISSN
Volume Title
Publisher
BMJ
Published Version
Abstract
Background: The SafeBoosC phase II randomised clinical trial recently demonstrated the benefits of a combination of cerebral regional tissue oxygen saturation (rStO2) by near-infrared spectroscopy (NIRS) and a treatment guideline to reduce the oxygen imbalance in extremely preterm infants. Aims: To analyse rStO2-alarm-related clinical decisions and their heterogeneity in the NIRS experimental group (NIRS monitoring visible) and their impact on rStO2 and SpO2. Methods: Continuous data from NIRS devices and the alarms (area under the curve of the rStO2 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 rStO2 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 (SpO2), were observed only after treatment guideline interventions. Conclusions: This study shows that 25% of rStO2 alarms were followed by a clinical intervention determined by the treatment guideline. However, the rStO2 and SpO2 returned to normal ranges after the intervention, supporting the notion that decisions taken by the clinicians were appropriate. Trial registration number: ClinicalTrial.gov NCT01590316.
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Keywords
SafeBoosC phase II , Clinical trial , Cerebral regional tissue , Near-infrared spectroscopy (NIRS) , Heterogeneity
Citation
Riera, J., Hyttel-Sorensen, S., Bravo, M. C., Cabañas, F., López-Ortego, P., Sanchez, L., Ybarra, M., Dempsey, E., Greisen, G., Austin, T., Claris, O., Fumagalli, M., Gluud, C., Lemmers, P., Pichler, G., Plomgaard, A. M., van Bel, F., Wolf, M. and Pellicer, A. (2016) 'The SafeBoosC phase II clinical trial: an analysis of the interventions related with the oximeter readings', Archives of Disease in Childhood - Fetal and Neonatal Edition, 101(4), pp. 333-338. doi: 10.1136/archdischild-2015-308829