Innovative nitric oxide delivery technology for postoperative pulmonary hypertension in congenital heart disease patients: a clinical trial
Abstract
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 NO2 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 PaO2/FiO2 increasing and PaCO2 decreasing…
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Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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