Department of Anesthesiology and Perioperative Medicine, Xijing Hospital, Xian, Shaanxi, China.
Anesthesia Clinical Research Center, Xijing Hospital, Xian, Shaanxi, China.
BMJ Open. 2024 Mar 14;14(3):e077572. doi: 10.1136/bmjopen-2023-077572.
A history of SARS-CoV-2 infection has been reported to be associated with an increased risk of postoperative pulmonary complications (PPCs). Even mild PPCs can elevate the rates of early postoperative mortality, intensive care unit (ICU) admission and prolong the length of ICU and/or hospital stays. Consequently, it is crucial to develop perioperative management strategies that can mitigate these increased risks in surgical patients who have recently been infected with SARS-CoV-2. Accumulating evidence suggests that nitric oxide (NO) inhalation might be effective in treating COVID-19. NO functions in COVID-19 by promoting vasodilation, anticoagulation, anti-inflammatory and antiviral effects. Therefore, our study hypothesises that the perioperative use of NO can effectively reduce PPCs in patients with recent SARS-CoV-2 infection.
A prospective, double-blind, single-centre, randomised controlled trial is proposed. The trial aims to include participants who are planning to undergo surgery with general anaesthesia and have been recently infected with SARS-CoV-2 (within 7 weeks). Stratified allocation of eligible patients will be performed at a 1:1 ratio based on the predicted risk of PPCs using the Assess Respiratory Risk in Surgical Patients in Catalonia risk index and the time interval between infection and surgery.The primary outcome of the study will be the presence of PPCs within the first 7 days following surgery, including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm and aspiration pneumonitis. The primary outcome will be reported as counts (percentage) and will be compared using a two-proportion χ test. The common effect across all primary components will be estimated using a multiple generalised linear model.
The trial is approved by the Institutional Review Board of Xijing Hospital (KY20232058-F1). The findings, including positive, negative and inconclusive results, will be published in scientific journals with peer-review processes.
NCT05721144.
有研究报道，SARS-CoV-2 感染史与术后肺部并发症（PPCs）风险增加相关。即使是轻度 PPCs 也会增加术后早期死亡率、重症监护病房（ICU）入院率，并延长 ICU 和/或住院时间。因此，对于近期感染 SARS-CoV-2 的手术患者，制定减轻这些风险的围手术期管理策略至关重要。越来越多的证据表明，吸入一氧化氮（NO）可能对治疗 COVID-19 有效。NO 在 COVID-19 中发挥作用的机制是促进血管扩张、抗凝、抗炎和抗病毒作用。因此，我们的研究假设围手术期使用 NO 可以有效降低近期 SARS-CoV-2 感染患者的 PPCs 发生率。
本研究拟采用前瞻性、双盲、单中心、随机对照试验。试验纳入计划接受全身麻醉手术且近期感染 SARS-CoV-2（7 周内）的患者。根据预测的 PPCs 风险（使用加泰罗尼亚外科患者呼吸风险评估指数和感染与手术之间的时间间隔），对符合条件的患者进行分层 1:1 随机分配。研究的主要结局为术后 7 天内是否发生 PPCs，包括呼吸道感染、呼吸衰竭、胸腔积液、肺不张、气胸、支气管痉挛和吸入性肺炎。主要结局将以计数（百分比）报告，并采用两比例 χ 检验进行比较。使用多广义线性模型估计所有主要成分的常见效果。
该试验已获得西京医院机构审查委员会的批准（KY20232058-F1）。研究结果，包括阳性、阴性和不确定结果，将在经过同行评审的科学期刊上发表。
NCT05721144。
