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The SafeBoosC phase II clinical trial: an analysis of the interventions related with the oximeter readings
  1. Joan Riera1,2,
  2. Simon Hyttel-Sorensen3,
  3. María Carmen Bravo1,
  4. Fernando Cabañas4,
  5. Paloma López-Ortego1,
  6. Laura Sanchez1,
  7. Marta Ybarra1,
  8. Eugene Dempsey5,
  9. Gorm Greisen3,
  10. Topun Austin6,
  11. Olivier Claris7,
  12. Monica Fumagalli8,
  13. Christian Gluud9,
  14. Petra Lemmers10,
  15. Gerhard Pichler11,
  16. Anne Mette Plomgaard1,
  17. Frank van Bel10,
  18. Martin Wolf12,
  19. Adelina Pellicer1
  1. 1Department of Neonatology, La Paz University Hospital, Madrid, Spain
  2. 2Center for Biomedical Technology, Technical University, Madrid, Spain
  3. 3Department of Neonatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
  4. 4Biomedical Research Foundation, La Paz University Hospital-IdiPAZ, Madrid, Spain
  5. 5Department of Paediatrics and Child Health, University College Cork, Cork, Ireland
  6. 6Rosie Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
  7. 7Department of Neonatology, Hopital Femme Mere Enfants, Bron, France
  8. 8NICU, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy
  9. 9Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
  10. 10University Medical Center Utrecht, Wilhelmina Children's Hospital, Utrecht, Netherlands
  11. 11Department of Pediatrics, Medical University of Graz, Graz, Austria
  12. 12Biomedical Optics Research Laboratory, Division of Neonatology, University Hospital Zurich, Zurich, Switzerland
  1. Correspondence to Joan Riera, Biomedical Engineer, Department of Neonatology, La Paz University Hospital, Paseo de la Castellana 261, Madrid ES-28046, Spain; joan.riera{at}


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 NCT01590316.

  • Neonatology
  • Intensive Care
  • Monitoring

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