Nitric Oxide, GeNO Nitrosyl Delivery System

Investigational product will be administered by qualified study staff in accordance with the procedures described in the protocol and in accordance with the detailed set of instructions supplied with the initial shipment of investigational product. Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM. In order to reliably measure trace levels of NO2 in the presence of a large excess of NO, it is essential to use a technique with extremely high accuracy in situations of low levels of NO2. The GeNO nitrosyl delivery system delivers a fixed concentration of 80ppm NO with low levels of NO2 which current technology cannot measure with accuracy at levels below 3ppm. The investigational product is the GeNO nitrosyl delivery system which consists of a drug/device combination product with all the components necessary to deliver the investigational drug; the nitric oxide gas. The investigational drug, nitric oxide, is generated at the time of use when the NO2 input gas flows through the cartridge, the antioxidant reduces the NO2 to NO. The input gas is supplied as either nitric oxide in air or nitric oxide in oxygen. The Investigator will determine whether air or oxygen is used as the balance gas, on the basis of the participant's clinical needs for supplemental oxygen.