Clinical Evaluation of an Automatic Oxygen Control System for Premature Infants Receiving High-Flow Nasal Cannula for Respiratory Support: A Pilot Study.

Abstract

A pilot clinical study was conducted that compared the peripheral oxygen saturation (SpO2) targeting performance of an automatic oxygen control system with manual oxygen control, which is the standard of care for preterm and low birth weight infants on high-flow nasal cannula (HFNC). The new oxygen control device studied was used to automatically adjust the fraction of inspired oxygen (FiO2) according to a desired SpO2 target setpoint and measured feedback signals including the SpO2 and other signals. A crossover study was designed with several endpoints including the comparison of the percentage of time that the SpO2 was within the target range with the automatic oxygen control device versus manual oxygen control. Other metrics were also compared to assess the performance of the system including the number of bradycardia events. The pilot study included six patients that fit the inclusion criteria. The results showed that there were improvements in all of the measured outcomes considered including statistically significant improvements in the number of bradycardia events during the period when the automatic oxygen control device was used.