Published in
BMJ Publishing Group, Archives of Disease in Childhood. Fetal and Neonatal Edition, 4(101), p. F333-F338, 2015
DOI: 10.1136/archdischild-2015-308829
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- [curis.ku.dk] | PDF
- [air.unimi.it] | PDF
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- [www.researchgate.net]
- [www.ncbi.nlm.nih.gov] | PDF
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Tools
The SafeBoosC phase II clinical trial: an analysis of the interventions related with the oximeter readings
,
Gorm Greisen ,
Topun Austin,
Olivier Claris,
Monica Fumagalli ,
Christian Gluud ,
F. Van Bel,
Petra Lemmers
and other authors.
Full text: Download
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