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Performance and safety of the PRICO closed-loop oxygen saturation targeting system in neonates: pragmatic multicentre cross-over study (TarOx Study)

M. Wilinska, T. Bachman, T. Szczapa, K. Wroblewska-Seniuk, K. Chojnacka, B. Loniewska, K. Olszanska, B. Rzepecka Weglarz, K. Janusz, P. Piwowarczyk, W. Onland, GJ. Hutten, RW. van Leuteren, AH. van Kaam

. 2024 ; 8 (1) : . [pub] 20240716

Language English Country England, Great Britain

Document type Journal Article, Multicenter Study, Randomized Controlled Trial, Pragmatic Clinical Trial

Persistent link   https://www.medvik.cz/link/bmc24019731

OBJECTIVE: This study aims to evaluate the performance of the fabian-Predictive-Intelligent-Control-of-Oxygenation (PRICO) system for automated control of the fraction of inspired oxygen (FiO2). DESIGN: Multicentre randomised cross-over study. SETTING: Five neonatal intensive care units experienced with automated control of FiO2 and the fabian ventilator. PATIENTS: 39 infants: median gestational age of 27 weeks (IQR: 26-30), postnatal age 7 days (IQR: 2-17), weight 1120 g (IQR: 915-1588), FiO2 0.32 (IQR: 0.22-0.43) receiving both non-invasive (27) and invasive (12) respiratory support. INTERVENTION: Randomised sequential 24-hour periods of automated and manual FiO2 control. MAIN OUTCOME MEASURES: Proportion (%) of time in normoxaemia (90%-95% with FiO2>0.21 and 90%-100% when FiO2=0.21) was the primary endpoint. Secondary endpoints were severe hypoxaemia (<80%) and severe hyperoxaemia (>98% with FiO2>0.21) and prevalence of episodes ≥60 s at these two SpO2 extremes. RESULTS: During automated control, subjects spent more time in normoxaemia (74%±22% vs 51%±22%, p<0.001) with less time above and below (<90% (9%±8% vs 12%±11%, p<0.001) and >95% with FiO2>0.21 (16%±19% vs 35%±24%) p<0.001). They spent less time in severe hyperoxaemia (1% (0%-3.5%) vs 5% (1%-10%), p<0.001) but exposure to severe hypoxaemia was low in both arms and not different. The differences in prolonged episodes of SpO2 were consistent with the times at extremes. CONCLUSIONS: This study demonstrates the ability of the PRICO automated oxygen control algorithm to improve the maintenance of SpO2 in normoxaemia and to avoid hyperoxaemia without increasing hypoxaemia.

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$a OBJECTIVE: This study aims to evaluate the performance of the fabian-Predictive-Intelligent-Control-of-Oxygenation (PRICO) system for automated control of the fraction of inspired oxygen (FiO2). DESIGN: Multicentre randomised cross-over study. SETTING: Five neonatal intensive care units experienced with automated control of FiO2 and the fabian ventilator. PATIENTS: 39 infants: median gestational age of 27 weeks (IQR: 26-30), postnatal age 7 days (IQR: 2-17), weight 1120 g (IQR: 915-1588), FiO2 0.32 (IQR: 0.22-0.43) receiving both non-invasive (27) and invasive (12) respiratory support. INTERVENTION: Randomised sequential 24-hour periods of automated and manual FiO2 control. MAIN OUTCOME MEASURES: Proportion (%) of time in normoxaemia (90%-95% with FiO2>0.21 and 90%-100% when FiO2=0.21) was the primary endpoint. Secondary endpoints were severe hypoxaemia (<80%) and severe hyperoxaemia (>98% with FiO2>0.21) and prevalence of episodes ≥60 s at these two SpO2 extremes. RESULTS: During automated control, subjects spent more time in normoxaemia (74%±22% vs 51%±22%, p<0.001) with less time above and below (<90% (9%±8% vs 12%±11%, p<0.001) and >95% with FiO2>0.21 (16%±19% vs 35%±24%) p<0.001). They spent less time in severe hyperoxaemia (1% (0%-3.5%) vs 5% (1%-10%), p<0.001) but exposure to severe hypoxaemia was low in both arms and not different. The differences in prolonged episodes of SpO2 were consistent with the times at extremes. CONCLUSIONS: This study demonstrates the ability of the PRICO automated oxygen control algorithm to improve the maintenance of SpO2 in normoxaemia and to avoid hyperoxaemia without increasing hypoxaemia.
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$a Bachman, Thomas $u Faculty Biomedical Engineering, Czech Technical University in Prague, Kladno, Czech Republic $1 https://orcid.org/0000000239689402
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$a Szczapa, Tomasz $u Neonatal Biophysical Monitoring and Cardiopulmonary Therapies Research Unit, Poznan University of Medical Sciences, Poznan, Poland $u II Department of Neonatology, Poznan University of Medical Sciences, Poznan, Poland $1 https://orcid.org/0000000252142719
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$a Wroblewska-Seniuk, Katarzyna $u Neonatal Biophysical Monitoring and Cardiopulmonary Therapies Research Unit, Poznan University of Medical Sciences, Poznan, Poland $u II Department of Neonatology, Poznan University of Medical Sciences, Poznan, Poland
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$a Chojnacka, Karolina $u Neonatal Biophysical Monitoring and Cardiopulmonary Therapies Research Unit, Poznan University of Medical Sciences, Poznan, Poland $u II Department of Neonatology, Poznan University of Medical Sciences, Poznan, Poland
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$a Loniewska, Beata $u Department of Neonatology, Pomeranian Medical University in Szczecin, Szczecin, Poland
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$a Olszanska, Karolina $u Department of Neonatology, Pomeranian Medical University in Szczecin, Szczecin, Poland
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$a Rzepecka Weglarz, Beata $u Department of Neonatology, Ujastek Medical Cetner, Krakow, Poland
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$a Janusz, Katarzyna $u Department of Neontology, Ujastek Medical Center, Krakow, Poland
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$a Piwowarczyk, Pawel $u Department of Neonatology, Centre for Postgraduate Medical Education, Warsaw, Poland
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$a van Leuteren, Ruud W $u Departent of Neonatology Emma Children's Hospital UMC, University of Amsterdam, Amsterdam, The Netherlands $u Amsterdam Reproduction & Development Research Institute, UMC, Amsterdam, The Netherlands
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$a van Kaam, Anton H $u Departent of Neonatology Emma Children's Hospital UMC, University of Amsterdam, Amsterdam, The Netherlands $u Amsterdam Reproduction & Development Research Institute, UMC, Amsterdam, The Netherlands
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