Pilot Project Aims To Improve Continuous Oxygen Therapy in the NICU

Maintaining consistent oxygen saturation in ventilator-dependent patients—and infants in particular—continues to be a challenge for providers. Available literature suggests that target levels of oxygen saturation might only be achieved around one-third of the day.

“No commercially available oxygen therapy exists today in the U.S. that offers 100% oxygen compliance,” says Hany Aly, MD, Chair of the Division of Neonatology at Cleveland Clinic Children’s. Instead, hospitals rely on nurses and care teams to manually adjust oxygen levels as needed, which can be incredibly laborious and time-intensive.

Putting the findings into context, Dr. Aly says, “Basically, if you are on a ventilator for 24 hours in the ICU, your oxygen saturation is on target for eight hours and abnormal for 16 hours—despite constant adjustments made throughout the day.”

Preventing hypoxemia and hyperoxemia

Maintaining target oxygen saturation (SpO₂) levels is essential in all critically ill patients who require supplemental oxygen, especially in neonatal and infant populations, where factors like gestational age and cardiovascular status can further complicate target SpO₂ levels.

However, attempts to mimic the nuance of natural breath have fallen short. “Our breathing is actually quite inconsistent, and our bodies keep adjusting to how much breath we need,” Dr. Aly explains. Compare this with a patient on a ventilator who is receiving a continuous rate and pressure. This often results in oxygen saturation levels that are too high or too low, increasing patients’ risk for life-threatening complications related to hypoxemia and hyperoxemia. When they should be hovering at 90%-95% SpO₂, he says.

Extending the window of optimal range

To address this, Dr. Aly and colleagues plan to develop a continuous oxygen monitoring prototype that would work with existing oxygen therapy systems, an idea made possible with a Catalyst Grant.

While closed-loop oxygen titrating systems have been developed in the past, none have achieved commercial success, and uncertainty remains about their safety and effectiveness.

“Our primary aim is to improve the percentage of time a patient is in a normal SpO₂ range while in the NICU or ICU and on a ventilator or CPAP machine. If we can maintain patient oxygenation on target most of the time, that would be fantastic,” says Dr. Aly.

The project is in the early development phase and will be completed in several steps. Dr. Aly and colleagues have tapped Cleveland Clinic biomedical engineers and programmers to develop a monitor prototype based on various clinical inputs. Once they have an integrated system, the next step will be to secure preliminary approval.

“Following the finalization of the design, build, and software development, the prototype will be tested in adjunct with standard ventilators using an in-house simulator to demonstrate continuous maintenance of the desired oxygen range,” he says.

Reconciling caregiver burden with patient care

Despite it being a no-win situation, Dr. Aly hopes that the organization’s investment in this innovation will lead to a much broader impact in intensive care management.

“When you see oxygen saturation levels are not where they should be, despite a care team doing everything they can, it means we need a better solution.”