Performance and safety of the PRICO closed-loop oxygen saturation targeting system in neonates: pragmatic multicentre cross-over study (TarOx Study)
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F68407700%3A21460%2F24%3A00380971" target="_blank" >RIV/68407700:21460/24:00380971 - isvavai.cz</a>
Result on the web
<a href="https://doi.org/10.1136/bmjpo-2024-002583" target="_blank" >https://doi.org/10.1136/bmjpo-2024-002583</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1136/bmjpo-2024-002583" target="_blank" >10.1136/bmjpo-2024-002583</a>
Alternative languages
Result language
angličtina
Original language name
Performance and safety of the PRICO closed-loop oxygen saturation targeting system in neonates: pragmatic multicentre cross-over study (TarOx Study)
Original language description
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 (FiO(2)). Design Multicentre randomised cross-over study. Setting Five neonatal intensive care units experienced with automated control of FiO(2) 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), FiO(2) 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 FiO(2) control. Main outcome measures Proportion (%) of time in normoxaemia (90%-95% with FiO(2)>0.21 and 90%-100% when FiO(2)=0.21) was the primary endpoint. Secondary endpoints were severe hypoxaemia (<80%) and severe hyperoxaemia (>98% with FiO(2)>0.21) and prevalence of episodes >= 60 s at these two SpO(2) 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 FiO(2)>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 SpO(2) 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 SpO(2) in normoxaemia and to avoid hyperoxaemia without increasing hypoxaemia.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
20601 - Medical engineering
Result continuities
Project
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Continuities
S - Specificky vyzkum na vysokych skolach
Others
Publication year
2024
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
BMJ Paediatrics Open
ISSN
2399-9772
e-ISSN
2399-9772
Volume of the periodical
8
Issue of the periodical within the volume
1
Country of publishing house
GB - UNITED KINGDOM
Number of pages
7
Pages from-to
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UT code for WoS article
001312956400001
EID of the result in the Scopus database
2-s2.0-105001272340