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Clinical Trial
. 2016 Jul;101(4):F333-8.
doi: 10.1136/archdischild-2015-308829. Epub 2015 Dec 8.

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

Joan Riera  1 , Simon Hyttel-Sorensen  2 , María Carmen Bravo  3 , Fernando Cabañas  4 , Paloma López-Ortego  3 , Laura Sanchez  3 , Marta Ybarra  3 , Eugene Dempsey  5 , Gorm Greisen  2 , Topun Austin  6 , Olivier Claris  7 , Monica Fumagalli  8 , Christian Gluud  9 , Petra Lemmers  10 , Gerhard Pichler  11 , Anne Mette Plomgaard  3 , Frank van Bel  10 , Martin Wolf  12 , Adelina Pellicer  3
Affiliations
Clinical Trial

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

Joan Riera et al. Arch Dis Child Fetal Neonatal Ed. 2016 Jul.

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.

Keywords: Intensive Care; Monitoring; Neonatology.

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Figures

Figure 1
Figure 1
Flow diagram describing the potential decisions offered in response to an alarm and the distribution of choices according to the clinical staff preference. PDA, patent ductus arteriosus.
Figure 2
Figure 2
Kaplan–Meier plot diagram representing the time needed for the alarm to be resolved according to type of decision taken (differences between ‘No action’ and ‘Treatment guideline intervention’ (p<0.001); ‘Alarm-prompted reposition’ (p=0.001); ‘Other’ (p=0.009)). Unresolved alarms, percentage of alarms that remain active.
Figure 3
Figure 3
Impact of type of decision taken in response to alarm episodes on the rStO2 and the peripheral oxygen saturation (SpO2) used as a physiological proxy of cerebral oxygen saturation (rStO2). The rStO2 (hypoxia, (A); hyperoxia, (B)) and SpO2 (C) averaged means (95% CI) at onset of the alarm and at first (30 min) and second (60 min) review are represented.
See this image and copyright information in PMC

References

    1. Hyttel-Sørensen S, Pellicer A, Alderliesten T, et al. . Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial. BMJ 2015;350:g7635 10.1136/bmj.g7635 - DOI - PMC - PubMed
    1. Pellicer A, Bravo Mdel C. Near-infrared spectroscopy: a methodology-focused review. Sem Fetal Neonatal Med 2011;16:42–9. 10.1016/j.siny.2010.05.003 - DOI - PubMed
    1. Wolf M, Greisen G. Advances in near-infrared spectroscopy to study the brain of the preterm and term neonate. Clin Perinatol 2009;36:807–34, vi 10.1016/j.clp.2009.07.007 - DOI - PubMed
    1. Nagdyman N, Fleck T, Schubert S, et al. . Comparison between cerebral tissue oxygenation index measured by near-infrared spectroscopy and venous jugular bulb saturation in children. Intensive Care Med 2005;31:846–50. 10.1007/s00134-005-2618-0 - DOI - PubMed
    1. Tyree K, Tyree M, DiGeronimo R. Correlation of brain tissue oxygen tension with cerebral near-infrared spectroscopy and mixed venous oxygen saturation during extracorporeal membrane oxygenation. Perfusion 2009;24:325–31. 10.1177/0267659109353966 - DOI - PubMed

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