Innovative nitric oxide delivery technology for postoperative pulmonary hypertension in congenital heart disease patients: a clinical trial.

BACKGROUND

Inhaled nitric oxide (iNO) is a selective pulmonary vasodilator with therapeutic benefits for pulmonary hypertension patients. Traditional cylinder-based iNO delivery systems are costly and complex, creating unmet medical needs. This study evaluated the safety and efficacy of a novel electrochemical nitric oxide generator (ENG) for administering iNO to adult patients with congenital heart disease-associated pulmonary arterial hypertension (CHD-PAH) in China following cardiac surgery.

METHODS

Twenty patients with CHD-PAH, undergoing cardiac surgery, were enrolled. Two hours post-surgery, when systemic circulation was stable, iNO was delivered via the ENG at 20 ppm. Clinical data were recorded, and iNO therapy was discontinued upon extubation. Safety, gas exchange, and hemodynamic parameters were analyzed before and at 2, 4, and 6 h post-treatment.

RESULTS

All patients received iNO treatment successfully and were discharged. The NO concentration remained stable, unaffected by ventilator settings, and NO levels stayed within a safe range. iNO did not impact systemic blood pressure (P > 0.05). No pulmonary hypertension crises or new complications occurred. INO was associated with reductions in systolic pulmonary artery pressure at 2, 4, and 6 h (P = 0.0053, P = 0.0218, P = 0.0002). In the hypoxemic subgroup demonstrated significant improvements in both oxygenation and ventilation parameters following iNO therapy, with PaO/FiO increasing and PaCO decreasing (P<0.05) at 6 h.

CONCLUSION

The ENG provided stable NO delivery, ensuring safety and efficacy in postoperative adult CHD-PAH patients. It was associated with improvements of hemodynamics and gas exchange without systemic side effects, offering a compact, efficient, and cost-effective alternative to traditional iNO delivery systems. This research was registered with the Clinical Trial Registry at http://www.chictr.org.cn , under the registration number ChiCTR2400091214. The submission occurred on March 25, 2024, and the registration was made publicly available on October 23, 2024.