TY - JOUR

T1 - The SafeBoosC phase II clinical trial

T2 - an analysis of the interventions related with the oximeter readings

AU - Riera, Joan

AU - Hyttel-Sorensen, Simon

AU - Bravo, María Carmen

AU - Cabañas, Fernando

AU - López-Ortego, Paloma

AU - Sanchez, Laura

AU - Ybarra, Marta

AU - Dempsey, Eugene

AU - Greisen, Gorm

AU - Austin, Topun

AU - Claris, Olivier

AU - Fumagalli, Monica

AU - Gluud, Christian

AU - Lemmers, Petra

AU - Pichler, Gerhard

AU - Plomgaard, Anne Mette

AU - van Bel, Frank

AU - Wolf, Martin

AU - Pellicer, Adelina

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

PY - 2016

Y1 - 2016

N2 - 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.

AB - 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.

U2 - 10.1136/archdischild-2015-308829

DO - 10.1136/archdischild-2015-308829

M3 - Journal article

C2 - 26645538

VL - 101

SP - F333-F338

JO - Archives of Disease in Childhood: Fetal and Neonatal Edition

JF - Archives of Disease in Childhood: Fetal and Neonatal Edition

SN - 1359-2998

IS - 4

ER -