Clinical Evaluation of a Closed Loop Oxygen Controller for Neonatal Respiratory Care

Nearly forty years ago Berran and coworkers tested an analog oxygen controller to maintain
incubator oxygen levels for infants suffering neonatal respiratory disease in order to
prevent hyperoxia.

1. The system was able to regulate to within 1% of the set inspired oxygen level and
resulted in stable infant arterial oxygen levels measured transcutaneously. Twenty
years later, with the advent of pulse oximetry and computer technology, open loop
control of infant oxygen saturation was studied in newborns using computer programs
incorporating fuzzy logic and clinical algorithms.

2. During computer-assisted inspired oxygen adjustment there was less variability in pulse
oximeter oxygen saturation levels (SpO2) and patients spent more time within the target
oxygen saturation range. The next technology step was to move from open to closed loop
control, as was done by Claure et al in 2001.

3. These investigators found that closed loop control of inspired oxygen was at least as
effective as a fully dedicated nurse in maintaining SpO2 within the target range, and
that it may be more effective than a nurse working under routine conditions. Percent
of recording time spent at normoxia increased from 66% to 75%. Other bench research
suggests that closed loop oxygen controllers based on SpO2 monitoring can have response
times within 20 seconds and be able to maintain SpO2 within three percent saturation.

4. In a clinical crossover trial it was shown that compared to routine inspired oxygen
control management by bedside personnel, closed loop control of inspired oxygen
concentration significantly increased time within target saturation range from 82% to
91%.

5. The importance of controlling oxygen exposure in neonates has been long standing,
especially as it relates to retinopathy of prematurity and bronchopulmonary dysplasia.
The prospect for decreasing oxygen related morbidities is still a real and an ongoing
topic for process change directed to overcoming treatment barriers.

6. Maintaining oxygen saturation tightly within appropriate treatment ranges appears to
improve both short and long term outcomes, including developmental indices.

7. Given the improvement in oxygen exposure that can be realized by closed-loop control of
inspired oxygen concentration as demonstrated above, the development of commercial
devices that incorporate this technology is highly desirable and a positive move toward
uniform control of oxygen exposure for neonates. There are at least three clinical
issues that this technology addresses: the first is avoidance of episodic hyperoxia;
the second is decreasing episodic hypoxia; and the third is lowering cumulative oxygen
exposure.

Inclusion Criteria:

- Any neonatal intensive care patient who is requiring oxygen therapy as part of their
respiratory treatment course will be eligible for this study.

- Parental consent

Exclusion Criteria:

- Infant on room air