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.
  
  
  OBJECTIVE
  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.
  
  
  BACKGROUND
  ClinicalTrial.gov NCT01590316.
authors.affiliation: Department of Neonatology, La Paz University Hospital, Madrid, Spain Center for Biomedical Technology, Technical University, Madrid, Spain.
authors.forename: Joan
authors.initials: J
authors.lastname: Riera
authors.affiliation: Department of Neonatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Simon
authors.initials: S
authors.lastname: Hyttel-Sorensen
authors.affiliation: Department of Neonatology, La Paz University Hospital, Madrid, Spain.
authors.forename: María Carmen
authors.initials: MC
authors.lastname: Bravo
authors.affiliation: Biomedical Research Foundation, La Paz University Hospital-IdiPAZ, Madrid, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Cabañas
authors.affiliation: Department of Neonatology, La Paz University Hospital, Madrid, Spain.
authors.forename: Paloma
authors.initials: P
authors.lastname: López-Ortego
authors.affiliation: Department of Neonatology, La Paz University Hospital, Madrid, Spain.
authors.forename: Laura
authors.initials: L
authors.lastname: Sanchez
authors.affiliation: Department of Neonatology, La Paz University Hospital, Madrid, Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: Ybarra
authors.affiliation: Department of Paediatrics and Child Health, University College Cork, Cork, Ireland.
authors.forename: Eugene
authors.initials: E
authors.lastname: Dempsey
authors.affiliation: Department of Neonatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Gorm
authors.initials: G
authors.lastname: Greisen
authors.affiliation: Rosie Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
authors.forename: Topun
authors.initials: T
authors.lastname: Austin
authors.affiliation: Department of Neonatology, Hopital Femme Mere Enfants, Bron, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Claris
authors.affiliation: NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Fumagalli
authors.affiliation: Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
authors.affiliation: University Medical Center Utrecht, Wilhelmina Children's Hospital, Utrecht, Netherlands.
authors.forename: Petra
authors.initials: P
authors.lastname: Lemmers
authors.affiliation: Department of Pediatrics, Medical University of Graz, Graz, Austria.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Pichler
authors.affiliation: Department of Neonatology, La Paz University Hospital, Madrid, Spain.
authors.forename: Anne Mette
authors.initials: AM
authors.lastname: Plomgaard
authors.affiliation: University Medical Center Utrecht, Wilhelmina Children's Hospital, Utrecht, Netherlands.
authors.forename: Frank
authors.initials: F
authors.lastname: van Bel
authors.affiliation: Biomedical Optics Research Laboratory, Division of Neonatology, University Hospital Zurich, Zurich, Switzerland.
authors.forename: Martin
authors.initials: M
authors.lastname: Wolf
authors.affiliation: Department of Neonatology, La Paz University Hospital, Madrid, Spain.
authors.forename: Adelina
authors.initials: A
authors.lastname: Pellicer
mesh_terms: D001921:Brain / Q000378:metabolism*; D061345:Early Medical Intervention / Q000379:methods / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D002534:Hypoxia, Brain / Q000175:diagnosis / Q000378:metabolism / Q000503:physiopathology / Q000628:therapy; D062071:Infant, Extremely Premature; D007231:Infant, Newborn; D008297:Male; D008991:Monitoring, Physiologic / Q000379:methods; D010101:Oxygen Consumption; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D016896:Treatment Outcome
keywords: Intensive Care; Monitoring; Neonatology