Predictive Intelligent Control of Oxygenation in Preterm Infants: A Two-Center Feasibility Study

Dijkman, Koen P.; Goos, Tom G.; Dieleman, Jeanne P.; Mohns, Thilo; Pul, Carola van; Andriessen, Peter; Kroon, Abraham A.; Niemarkt, Hendrik J.

doi:10.1159/000527539

Cited by 2 publications

(3 citation statements)

References 25 publications

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“…One study by Dijkman et al , only included infants on HFNC, which allows for a large leak at the nasal interface. 13 Two of the previous studies used a broader SpO 2 target range (88%–95%) 13 17 and a shorter measurement period (8 hours), 17 which may also have impacted performance. Finally, there were differences in the patient characteristics, such as gestational age, respiratory support modalities and the postnatal age at inclusion.…”

Section: Discussionmentioning

confidence: 99%

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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)

Wilinska,

Bachman,

Szczapa

et al. 2024

bmjpo

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ObjectiveThis 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).DesignMulticentre randomised cross-over study.SettingFive neonatal intensive care units experienced with automated control of FiO2and the fabian ventilator.Patients39 infants: median gestational age of 27 weeks (IQR: 26–30), postnatal age 7 days (IQR: 2–17), weight 1120 g (IQR: 915–1588), FiO20.32 (IQR: 0.22–0.43) receiving both non-invasive (27) and invasive (12) respiratory support.InterventionRandomised sequential 24-hour periods of automated and manual FiO2control.Main outcome measuresProportion (%) 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 SpO2extremes.ResultsDuring 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 SpO2were consistent with the times at extremes.ConclusionsThis study demonstrates the ability of the PRICO automated oxygen control algorithm to improve the maintenance of SpO2in normoxaemia and to avoid hyperoxaemia without increasing hypoxaemia.

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Section: Discussionmentioning

confidence: 99%

“…As an example, two recent reports suggest the relative effectiveness of A-FiO 2 compared with M-FiO 2 is most marked in unstable infants. 17 18 …”

Section: Discussionmentioning

confidence: 99%

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

Wilinska,

Bachman,

Szczapa

et al. 2024

bmjpo

View full text Add to dashboard Cite

show abstract

“…Our study did not evaluate A-FiO 2 performance compared to manual control. However, this device has been evaluated by others in 24-h cross-over studies ( 18 , 19 ). These two investigations reported time in the target range and time >98% during A-FiO 2 , which were comparable to our findings.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the impact of oximeter averaging times on automated FiO2 control in routine NICU care: a randomized cross-over study

Janota,

Dornakova,

Karadyova

et al. 2023

Front. Pediatr.

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ObjectiveChanges in oximeter averaging times have been noted to affect alarm settings. Automated algorithms (A-FiO2) assess FiO2 faster than oximeter averaging, potentially impacting their effectiveness.MethodsIn a single NICU routinely using 15 fabian-PRICO A-FiO2 systems, neonates were randomly exposed to SpO2 averaging time settings switched every 12 h among short (2–4 s), medium (10 s), and long (16 s) oximeter averaging times for the entire duration of their A-FiO2 exposure. Primary endpoints were the percent time in the set SpO2 target range (dependent on PMA), SpO2 < 80%, and SpO2 > 98%, excluding FiO2 = 0.21.ResultsTen VLBW neonates were enrolled over 11 months. At entry, they were 17 days old (IQR: 14–19), with an adjusted gestational age of 29 weeks (IQR: 27–30). The study included data from 272 days of A-FiO2 control (34% short, 32% medium, and 34% long). Respiratory support was predominantly non-invasive (53% NCPAP, 40% HFNC, and 6% NIPPV). The aggregate SpO2 exposure levels were 67% (IQR: 55–82) in the target range, 5.4% (IQR: 2.0–10) with SpO2 < 80%, and 1.2% (IQR: 0.4–3.1) with SpO2 > 98%. There were no differences in the target range time between the SpO2 averaging time settings. There were differences at the SpO2 extremes (p ≤ 0.001). The medium and long averaging were both lower than the short, with the difference larger than predicted. Multivariate analysis revealed that these findings were independent of subject, ventilation mode, target range, and overall stability.ConclusionsThis A-FiO2 algorithm is effective regardless of the SpO2 averaging time setting. There is an advantage to the longer settings, which suggest an interaction with the controller.

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Predictive Intelligent Control of Oxygenation in Preterm Infants: A Two-Center Feasibility Study

Cited by 2 publications

References 25 publications

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

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

Evaluation of the impact of oximeter averaging times on automated FiO2 control in routine NICU care: a randomized cross-over study

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