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

Joan Riera; Simon Hyttel-Sorensen; María Carmen Bravo; Fernando Cabañas; Paloma López-Ortego; Laura Sanchez; Marta Ybarra; Eugene Dempsey; Gorm Greisen; Topun Austin; Olivier Claris; Monica Fumagalli; Christian Gluud; Petra Lemmers; Gerhard Pichler; Anne Mette Plomgaard; Frank van Bel; Martin Wolf; Adelina Pellicer

doi:10.1136/archdischild-2015-308829

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

Joan Riera, Simon Hyttel-Sorensen, María Carmen Bravo, Fernando Cabañas, Paloma López-Ortego, Laura Sanchez, Marta Ybarra, Eugene Dempsey, Gorm Greisen, Topun Austin, Olivier Claris, Monica Fumagalli, Christian Gluud, Petra Lemmers, Gerhard Pichler, Anne Mette Plomgaard, Frank van Bel, Martin Wolf, Adelina Pellicer

Department of Clinical Medicine

10 Citations (Scopus)

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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.

Original language	English
Journal	Archives of Disease in Childhood. Fetal and Neonatal Edition
Volume	101
Issue number	4
Pages (from-to)	F333-F338
Number of pages	6
ISSN	1359-2998
DOIs	https://doi.org/10.1136/archdischild-2015-308829
Publication status	Published - 1 Jul 2016

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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., & 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), F333-F338. https://doi.org/10.1136/archdischild-2015-308829

The SafeBoosC phase II clinical trial : an analysis of the interventions related with the oximeter readings. / Riera, Joan; Hyttel-Sorensen, Simon; Bravo, María Carmen et al.

In: Archives of Disease in Childhood. Fetal and Neonatal Edition, Vol. 101, No. 4, 01.07.2016, p. F333-F338.

Research output: Contribution to journal › Journal article › Research › peer-review

Riera, J, Hyttel-Sorensen, S, Bravo, MC, 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, AM, van Bel, F, Wolf, M & 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, vol. 101, no. 4, pp. F333-F338. https://doi.org/10.1136/archdischild-2015-308829

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

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.",

author = "Joan Riera and Simon Hyttel-Sorensen and Bravo, {Mar{\'i}a Carmen} and Fernando Caba{\~n}as and Paloma L{\'o}pez-Ortego and Laura Sanchez and Marta Ybarra and Eugene Dempsey and Gorm Greisen and Topun Austin and Olivier Claris and Monica Fumagalli and Christian Gluud and Petra Lemmers and Gerhard Pichler and Plomgaard, {Anne Mette} and {van Bel}, Frank and Martin Wolf and Adelina Pellicer",

note = "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/",

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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 - 2016/7/1

Y1 - 2016/7/1

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

SN - 1359-2998

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

IS - 4

ER -

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

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