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Original research
Automatic oxygen control for reducing extremes of oxygen saturation: a randomised controlled trial
  1. Vrinda Nair1,2,
  2. Prakash Kannan Loganathan3,
  3. Mithilesh Kumar Lal1,
  4. Helen Pringleton1,
  5. Thomas Edward Bachman4,
  6. Malcolm Brodlie2,5,
  7. Paul Dixon6
  1. 1 Neonatology, James Cook University Hospital, Middlesbrough, UK
  2. 2 Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK
  3. 3 Neonatal Intensive Care Unit, James Cook University Hospital, Middlesbrough, UK
  4. 4 Biomedical Engineering, Czech Technical University in Prague, Praha, Czech Republic
  5. 5 Paediatric Respiratory Medicine, Great North Children's Hospital, Newcastle Upon Tyne, UK
  6. 6 Vyaire Medical Products, Basingstoke, UK
  1. Correspondence to Dr Vrinda Nair, Neonatology, James Cook University Hospital, Middlesbrough, TS4 3BW, UK; vrinda.nair1{at}nhs.net

Abstract

Objective The objective of this study was to evaluate the efficacy of the automatic oxygen control (A-Fio2) in reducing the percentage of time spent in severe hypoxaemia (Spo2 <80%) in preterm infants for the time period on invasive ventilation and/or nasal continuous positive airway pressure (NCPAP) delivered by AVEA ventilator.

Design A parallel arm randomised controlled trial.

Setting A level-III neonatal intensive care unit.

Patients Preterm infants (<33 weeks birth gestation) who received invasive ventilation or NCPAP in the first 72 hours of age.

Interventions A-Fio2 vs manual (M-Fio2) oxygen control.

Outcomes The primary outcome of the study was percentage of time spent in severe hypoxaemia (Spo2 <80%).

Results 44 infants were randomised to either A-Fio2 or M-Fio2 arm and continued in the study for the period of respiratory support (invasive ventilation and/or NCPAP). The total number of study days in A-Fio2 and M-Fio2 arm were 194 and 204 days, respectively. The percentage of time spent in Spo2 <80% was significantly lower with A-Fio2 compared with M-Fio2 (median of 0.1% (IQR: 0.07–0.7) vs 0.6% (0.2–2); p=0.03). The number of prolonged episodes (>60 s) of Spo2 <80% per day was also significantly lower in A-Fio2 (0.3 (0.0–2) vs 2 (0.6–6); p=0.02).

Conclusion A-Fio2 was associated with statistically significant reduction in the percentage of time spent in severe hypoxaemia when compared with M-Fio2 in preterm infants receiving respiratory support.

Trial registration number NCT04223258.

  • Neonatology
  • Intensive Care Units, Neonatal

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

http://dx.doi.org/10.1136/archdischild-2022-324160

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    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information.

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    Footnotes

    • Contributors VN, PKL and MKL conceptualised and designed the study, collected the data, carried out the initial analysis, drafted the initial manuscript, reviewed and revised the manuscript. HP designed the study, collected the data and reviewed the manuscript. TEB designed the study, extracted the data from data loggers, carried out the statistical analysis, reviewed and revised the manuscript. MB designed the study, reviewed the data and reviewed the manuscript. PD designed the study, designed data collection instruments and software, extracted the data and reviewed the manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work. VN accepts full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Disclaimer The authors have no financial relationships relevant to this article to disclose.

    • 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.