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Arch Dis Child Fetal Neonatal Ed. 2018 Nov 21. pii: fetalneonatal-2018-315342. doi: 10.1136/archdischild-2018-315342. [Epub ahead of print]

Randomised cross-over study of automated oxygen control for preterm infants receiving nasal high flow.

Author information

1
Neonatal Intensive Care Unit, Ashford and St Peter's Hospitals NHS Foundation Trust, Chertsey, Surrey, UK.
2
School of Biological Sciences, Royal Holloway University of London, Egham, UK.
3
Sidney Kimmel Medical College, Philadelphia, Pennsylvania, USA.
4
Vixiar Medical, Baltimore, Massachusetts, USA.
5
Vapotherm, Exeter, New Hampshire, USA.
6
Canisius College, Buffalo, New York, USA.
7
Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
8
Medical Sciences Division, Department of Paediatrics, University of Oxford, Oxford, UK.

Abstract

OBJECTIVE:

To evaluate a prototype automated controller (IntellO2) of the inspired fraction of oxygen (FiO2) in maintaining a target range of oxygen saturation (SpO2) in preterm babies receiving nasal high flow (HF) via the Vapotherm Precision Flow.

DESIGN:

Prospective two-centre order-randomised cross-over study.

SETTING:

Neonatal intensive care units.

PATIENTS:

Preterm infants receiving HF with FiO2 ≥25%.

INTERVENTION:

Automated versus manual control of FiO2 to maintain a target SpO2 range of 90%-95% (or 90%-100% if FiO2=21%).

MAIN OUTCOME MEASURES:

The primary outcome measure was per cent of time spent within target SpO2 range. Secondary outcomes included the overall proportion and durations of SpO2 within specified hyperoxic and hypoxic ranges and the number of in-range episodes per hour.

RESULTS:

Data were analysed from 30 preterm infants with median (IQR) gestation at birth of 26 (24-27) weeks, study age of 29 (18-53) days and study weight 1080 (959-1443) g. The target SpO2 range was achieved 80% of the time on automated (IntellO2) control (IQR 70%-87%) compared with 49% under manual control (IQR 40%-57%; p<0.0001). There were fewer episodes of SpO2 below 80% lasting at least 60 s under automated control (0 (IQR 0-1.25)) compared with manual control (5 (IQR 2.75-14)). There were no differences in the number of episodes per hour of SpO2 above 98% (4.5 (IQR 1.8-8.5) vs 5.5 (IQR 1.9-14); p=0.572) between the study arms.

CONCLUSIONS:

The IntellO2 automated oxygen controller maintained patients in the target SpO2 range significantly better than manual adjustments in preterm babies receiving HF.

TRIAL REGISTRATION NUMBER:

NCT02074774.

KEYWORDS:

automatic oxygen control; blood oxygen saturation; closed loop; IntellO2 ; high flow; high flow nasal cannula; monitoring; neonatal intensive care; preterm babies

Conflict of interest statement

Competing interests: PRR and KI have received travel support and undertaken consulting work for Vapotherm. TLM, LIV and GCD were employees of Vapotherm during the study. NH and CCR have no declarations.

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