The study’s results were highlighted in a poster titled “On-Demand Nitric Oxide for Ventilator-Based Nitric Oxide Inhalation: A Risk-Reduction Perspective,” presented by Mark Rimkus, vice president of AIT Clinical Affairs, at the 2019 International Society for Aerosols in Medicine (ISAM) Congress, held May 25-29 in Montreux, Switzerland.
NO is a strong vasodilator that opens up blood vessels. This gas targets vascular smooth muscle cells that surround arteries, causing them to relax. In the lung, NO decreases resistance to blood flow and increases oxygenation, helping adults with respiratory distress syndrome and newborns with persistent PH.
The gas is usually administered with the use of high pressure cylinders placed next to the ventilation device in the patient’s bed — which often is located in a hospital’s intensive care unit. The size, weight, and presence of other equipment can make it difficult to manage the cylinders, posing a high potential risk for physical injuries to healthcare professionals.
The researchers said the standard NO cylinders also can pose a health risk to patients.
In these standard cylinders, the gas is provided at a fixed flow from an NO mixture with nitrogen, and added to breathing gas stream. If exposed to oxygen, NO rapidly transforms into nitrogen dioxide, which is toxic to tissues even in low concentrations. If an NO source is exposed to oxygen even for a few minutes, the medicine must be flushed from the system. Exposure to nitrogen dioxide is a serious health risk for patients and hospital personnel, the researchers said.
The researchers said there also are fluctuations of the inspired oxygen that go unnoticed in current delivery systems, and that expose patients to extra risks.
In contrast, the on-demand NO system developed by AIT delivers the gas using room air so it does not need cylinders. That minimizes the exposure of NO to oxygen and decreases the effects of inspired oxygen set by the ventilator, according to the company.
This system is compatible with current ventilator systems, making the transition from cylinders to the AIT system easier.
In the study, researchers compared the risk for 17 parameters when using AIT’s on-demand NO generator-based system versus standard NO cylinders. In particular, the team analyzed the risk of high NO exposure and of inspired oxygen (FiO2) for the patient, as well as the risk of physical injury to the health staff.
Results showed that using the AIT NO on-demand system decreased the risk of patients’ exposure to nitrogen dioxide, and reduced changes in FiO2 —decreasing the risk from a moderate level to essentially non-existent.
Additionally, the risks for nitrogen dioxide exposure, and of physical injury, for health workers were minimal with AIT’s on-demand NO system versus the standard NO cylinders.
“[T]his study clearly shows the safety benefits of on-demand NO, and we believe our ventilator-compatible Nitric Oxide Generator and Delivery System is the way of the future,” Steve Lisi, chairman and AIT CEO, said in a press release.
“Eliminating the need for high-pressure NO cylinders in the hospital setting can bring tangible benefits, and we look forward to providing hospitals with a cost-effective, risk-reducing solution,” Lisi added.
AIT acquired the rights for the NO delivery system from NitricGen in January 2018.