预防性高流量鼻氧疗与常规氧疗对预防术后呼吸系统并发症的效果：一项随机试验。
完整摘要 · 中文译文
背景：术后肺部并发症（PPCs）是肺切除术后发病的主要原因，尤其是在老年人中。拔管后，无创呼吸支持策略越来越多地用于预防呼吸功能恶化，但预防性经鼻高流量吸氧（HFNC）在此背景下的作用仍不确定。 方法：在这项单中心、开放标签随机对照试验中，因I-IIIa期非小细胞肺癌（NSCLC）接受电视辅助胸腔镜手术（VATS）肺叶切除术或肺段切除术的患者被随机分配至HFNC或传统氧疗（COT）组。主要结局是住院期间PPC的严重程度，采用序数逻辑回归分析；同时还比较了两组间临床相关PPC（≥2级）的发生率。次要结局包括纵向呼吸症状（mMRC、LCQ-MC、sCSS）和症状相关功能干扰（MDASI-LC），采用混合效应模型分析。 结果：共有210例患者纳入改良意向治疗分析（HFNC组，n = 104；COT组，n = 106）。HFNC降低了PPC严重程度（序数OR，0.50；95% CI，0.28-0.91；P = 0.022）和中重度PPC的发生率（23.1% vs. 39.6%；绝对风险差，-15.6%；95% CI，-28.0%至-3.2%；P = 0.010）。HFNC与较低的临床相关PPC负担相关。次要分析还提示术后早期呼吸症状及症状相关功能干扰有所改善。次要分析还提示术后早期呼吸 呼吸道症状及症状相关功能干扰。生理结局或住院时间未见差异。 结论：在接受肺切除术的老年人中，预防性经鼻高流量氧疗（HFNC）降低了院内术后肺部并发症（PPC）负担，并与更有利的术后早期呼吸恢复相关。这些发现提示，预防性HFNC作为一种潜在的预防性呼吸支持选择，可能使特定的老年或较高风险的术后患者获益，但本研究结果不支持对所有接受肺切除术的患者常规预防性使用。 试验注册：本研究于2022年9月1日获中国临床试验注册中心批准（ChiCTR2200063161），首例患者在预注册后入组。
完整摘要 · 英文原文
BACKGROUND: Postoperative pulmonary complications (PPCs) are a major cause of morbidity after lung resection, particularly in older adults. Following extubation, noninvasive respiratory support strategies are increasingly used to prevent respiratory deterioration, but the role of prophylactic high-flow nasal cannula (HFNC) in this setting remains uncertain. METHODS: In this single-center, open-label randomized controlled trial, patients undergoing video-assisted thoracoscopic surgery (VATS) lobectomy or segmentectomy for stage I-IIIa non-small cell lung cancer (NSCLC) were randomized to HFNC or conventional oxygen therapy (COT). The primary outcome was PPC severity during hospitalization, analyzed using ordinal logistic regression; the incidence of clinically relevant PPCs (grade ≥ 2) was also compared between groups. Secondary outcomes included longitudinal respiratory symptoms (mMRC, LCQ-MC, sCSS) and symptom-related functional interference (MDASI-LC), analyzed using mixed-effects models. RESULTS: A total of 210 patients were included in the modified intention-to-treat analysis (HFNC, n = 104; COT, n = 106). HFNC reduced PPC severity (ordinal OR, 0.50; 95% CI, 0.28-0.91; P = 0.022) and moderate-to-severe PPCs (23.1% vs. 39.6%; absolute risk difference, -15.6%; 95% CI, -28.0% to -3.2%; P = 0.010). HFNC was associated with a lower burden of clinically relevant PPCs. Secondary analyses also suggested improvements in early postoperative respiratory symptoms and symptom-related functional interference. Secondary analyses also suggested improvements in early postoperative respiratory symptoms and symptom-related functional interference. No differences were observed in physiological outcomes or length of stay. CONCLUSION: In older adults undergoing lung resection, prophylactic HFNC reduced in-hospital PPC burden and was associated with more favorable early postoperative respiratory recovery. These findings suggest that prophylactic HFNC may provide benefit as a potential preventive respiratory support option in selected older or higher-risk postoperative patients, although routine prophylactic use in all patients undergoing lung resection is not supported by the present findings. TRIAL REGISTRATION: This study was approved by the Chinese Clinical Trial Registry (ChiCTR2200063161) on 01 Sep 2022 and the first patient was enrolled after pre-registration.