In November 2018, the Archives of Disease in Childhood: Fetal & Neonatal edition published the results of a prospective, two-center, order-randomized cross-over study performed at two NICUs in the UK, designed to evaluate the performance of Vapotherm’s® forthcoming Oxygen Assist Module (OAM) technology. OAM is a module for the Precision Flow® system, designed to be used with Hi-VNI® Technology to help clinicians maintain neonates’ oxygen levels within a tight SpO2 range. It adjusts delivered FiO2 in response to SpO2 readings captured by a standard pulse oximetry probe.
The target SpO2 range set in this study was 90-95% in preterm babies being supported by Hi-VNI Technology. Babies were randomized to receive 24 hours of either Manual Control or Automatic Control using OAM. After the first 24 hours, the babies were crossed over to the alternative therapy for another 24 hours. The primary outcome measure was per cent of time spent within the target SpO2 range. Secondary outcomes included the overall proportion and durations of SpO2 within specified hyperoxic and hypoxic ranges, and characteristics of the times within and outside SpO2 target range. Data were analyzed from 30 preterm infants with median (IQR) gestation at birth of 26 (24–27) weeks, age during the study of 29 (18–53) days and study weight 1080 (959–1443) g.
When using OAM clinician performance in maintaining SpO2 within the target SpO2 range was significantly higher than during manual control alone. The median target SpO2 range was achieved 80% of the time on automated (OAM) control (IQR 70%–87%) compared with 49% under manual control (IQR 40%–57%; p<0.0001). In addition to the greater proportion of time in range, there were also fewer episodes of transient hypoxemia (defined as SpO2 below 80% lasting at least 60 seconds) under automated control (median 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, but the average episode duration and the total percentage of time spent above the SpO2 target range was significantly lower under OAM automated control as compared to Manual control.
This initial evaluation of the OAM prototype demonstrated the ability to maintain SpO2 within target ranges, which shows promise for the development of a much-needed tool for assisting bedside caregivers in the critical function of maintaining optimal FiO2 titration. The OAM used in the study is a prototype system and a commercial version is currently under development. The study referred to OAM as IntellO2.