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  • Predictive Intelligent Control of Oxygenation (PRICO) in preterm infants on high flow nasal cannula support: a randomised cross-over study

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Original research
Predictive Intelligent Control of Oxygenation (PRICO) in preterm infants on high flow nasal cannula support: a randomised cross-over study
  1. Koen P Dijkman1,
  2. Thilo Mohns1,
  3. Jeanne P Dieleman2,
  4. Carola van Pul3,4,
  5. Tom G Goos5,
  6. Irwin KM Reiss5,
  7. Peter Andriessen1,4,
  8. Hendrik J Niemarkt1
  1. 1 Neonatology, Maxima Medical Centre, Veldhoven, The Netherlands
  2. 2 MMC Academy, Maxima Medical Centre, Veldhoven, The Netherlands
  3. 3 Clinical Physics, Maxima Medical Centre, Veldhoven, The Netherlands
  4. 4 Applied Physics, University of Technology Eindhoven, Eindhoven, The Netherlands
  5. 5 Neonatology, Erasmus MC, Rotterdam, The Netherlands
  1. Correspondence to Koen P Dijkman, Neonatology, Maxima Medical Centre, Veldhoven, The Netherlands; k.dijkman{at}mmc.nl

Abstract

Objective To investigate the efficacy of automated control of inspired oxygen (FiO2) by Predictive Intelligent Control of Oxygenation (PRICO) on the Fabian ventilator in maintaining oxygen saturation (SpO2) in preterm infants on high flow nasal cannula (HFNC) support.

Design Single-centre randomised two-period crossover study.

Setting Tertiary neonatal intensive care unit.

Patients 27 preterm infants (gestational age (GA) <30 weeks) on HFNC support with FiO2 >0.25.

Intervention A 24-hour period on automated FiO2-control with PRICO compared with a 24-hour period on routine manual control (RMC) to maintain a SpO2 level within target range of 88%–95% measured at 30 s intervals.

Main outcome measures Primary outcome: time spent within target range (88%–95%). Secondary outcomes: time spent above and below target range, in severe hypoxia (SpO2 <80%) and hyperoxia (SpO2 >98%), mean SpO2 and FiO2 and manual FiO2 adjustments.

Results 15 patients received PRICO-RMC and 12 RMC-PRICO. The mean time within the target range increased with PRICO: 10.8% (95% CI 7.6 to 13.9). There was a decrease in time below target range: 7.6% (95% CI 4.2 to 11.0), above target range: 3.1% (95% CI 2.9 to 6.2) and in severe hypoxia: 0.9% (95% CI 1.5 to 0.2). We found no difference in time spent in severe hyperoxia. Mean FiO2 was higher during PRICO: 0.019 (95% CI 0.006 to 0.030). With PRICO there was a reduction of manual adjustments: 9/24 hours (95% CI 6 to 12).

Conclusion In preterm infants on HFNC support, automated FiO2-control by PRICO is superior to RMC in maintaining SpO2 within target range. Further validation studies with a higher sample frequency and different ventilation modes are needed.

  • neonatology
  • technology

Data availability statement

Data and deidentified patient data are available upon a reasonable request to the corresponding author.

https://doi.org/10.1136/archdischild-2020-320728

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    Data availability statement

    Data and deidentified patient data are available upon a reasonable request to the corresponding author.

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    Footnotes

    • Contributors KPD: study design, data acquisition, data analysis and interpretation, manuscript drafting and revision. TM: study design, data acquisition, critical manuscript revision. JPD: data and statistical analysis, critical manuscript revision. CvP: data analysis, critical manuscript revision. TGG: data analysis, critical manuscript revision. IKMR: data interpretation, critical manuscript revision. PA: study design, critical manuscript revision. HJN: study design, data acquisition, data interpretation, critical manuscript revision. All authors approve of the final version of the manuscript and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

    • Funding This study was supported by an unrestricted research grant from Chiesi Pharmaceuticals BV, The Netherlands.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.