Liu Ruofan, Li Yuntao, Li Bin, Liu Shen, Tong Minghui, Ma Qiong
Department of Cardiac Surgery, Peking University International Hospital, No.1 Life Garden Road, Zhongguancun Life Science Park, Changping District, Beijing, 102206, China.
BMC Cardiovasc Disord. 2025 Jul 18;25(1):522. doi: 10.1186/s12872-025-04967-3.
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.
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.
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.
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.
吸入一氧化氮（iNO）是一种选择性肺血管扩张剂，对肺动脉高压患者具有治疗作用。传统的基于气瓶的iNO输送系统成本高昂且复杂，存在未满足的医疗需求。本研究评估了一种新型电化学一氧化氮发生器（ENG）在中国心脏手术后成年先天性心脏病相关性肺动脉高压（CHD-PAH）患者中给予iNO的安全性和有效性。
招募了20例接受心脏手术的CHD-PAH患者。术后2小时，当体循环稳定时，通过ENG以20 ppm的浓度输送iNO。记录临床数据，拔管后停止iNO治疗。分析治疗前以及治疗后2、4和6小时的安全性、气体交换和血流动力学参数。
所有患者均成功接受iNO治疗并出院。NO浓度保持稳定，不受呼吸机设置影响，且NO水平保持在安全范围内。iNO对体循环血压无影响（P > 0.05）。未发生肺动脉高压危象或新的并发症。在2、4和6小时时，iNO与收缩期肺动脉压降低相关（P = 0.0053、P = 0.0218、P = 0.0002）。在低氧血症亚组中，iNO治疗后氧合和通气参数均有显著改善，6小时时PaO/FiO升高，PaCO降低（P < 0.05）。
ENG提供了稳定的NO输送，确保了成年CHD-PAH术后患者的安全性和有效性。它与血流动力学和气体交换的改善相关，且无全身副作用，为传统iNO输送系统提供了一种紧凑、高效且经济高效的替代方案。本研究已在http://www.chictr.org.cn的临床试验注册中心注册，注册号为ChiCTR2400091214。提交时间为2024年3月25日，注册信息于2024年10月23日公开。
