Performance and safety of the PRICO closed-loop oxygen saturation targeting system in neonates: pragmatic multicentre cross-over study (TarOx Study).
BMJ Paediatr Open
; 8(1)2024 Jul 16.
Article
en En
| MEDLINE
| ID: mdl-39019542
ABSTRACT
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 OUTCOMEMEASURES:
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.Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Unidades de Cuidado Intensivo Neonatal
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Estudios Cruzados
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Saturación de Oxígeno
Límite:
Female
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Humans
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Male
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Newborn
Idioma:
En
Revista:
BMJ Paediatr Open
Año:
2024
Tipo del documento:
Article
País de afiliación:
Polonia