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

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dc.contributor.authorRiera, Joan
dc.contributor.authorHyttel-Sorensen, Simon
dc.contributor.authorBravo, María Carmen
dc.contributor.authorCabañas, Fernando
dc.contributor.authorLópez-Ortego, Paloma
dc.contributor.authorSanchez, Laura
dc.contributor.authorYbarra, Marta
dc.contributor.authorDempsey, Eugene M.
dc.contributor.authorGreisen, Gorm
dc.contributor.authorAustin, Topun
dc.contributor.authorClaris, Olivier
dc.contributor.authorFumagalli, Monica
dc.contributor.authorGluud, Christian
dc.contributor.authorLemmers, Petra
dc.contributor.authorPichler, Gerhard
dc.contributor.authorPlomgaard, Anne Mette
dc.contributor.authorvan Bel, Frank
dc.contributor.authorWolf, Martin
dc.contributor.authorPellicer, Adelina
dc.contributor.funderStrategiske Forskningsråden
dc.contributor.funderSAMIDen
dc.date.accessioned2019-11-26T12:41:47Z
dc.date.available2019-11-26T12:41:47Z
dc.date.issued2016-06-17
dc.description.abstractBackground: 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.en
dc.description.sponsorshipDanish Council for Strategic Research (DKK 11 100 105); SAMID network (RD08/0072/0018 and RD12/0026/0004)en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationRiera, 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-2015-308829en
dc.identifier.doi10.1136/archdischild-2015-308829en
dc.identifier.eissn1468-2052
dc.identifier.endpage338en
dc.identifier.issn1359-2998
dc.identifier.issued4en
dc.identifier.journaltitleArchives of Disease in Childhood: Fetal and Neonatal Editionen
dc.identifier.startpage333en
dc.identifier.urihttps://hdl.handle.net/10468/9255
dc.identifier.volume101en
dc.language.isoenen
dc.publisherBMJen
dc.rights© 2016, The Author(s). This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/en
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/en
dc.subjectSafeBoosC phase IIen
dc.subjectClinical trialen
dc.subjectCerebral regional tissueen
dc.subjectNear-infrared spectroscopy (NIRS)en
dc.subjectHeterogeneityen
dc.titleThe SafeBoosC phase II clinical trial: An analysis of the interventions related with the oximeter readingsen
dc.typeArticle (peer-reviewed)en
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