BACKGROUND Patients with fibrotic interstitial lung disease (FILD) often experience gas exchange abnormalities and ventilatory limitations, resulting in reduced exercise capacity. High-flow nasal cannula (HFNC) oxygen therapy is a novel treatment, whose physiological beneficial effects have been demonstrated in various clinical settings. We hypothesized that HFNC oxygen therapy might be superior to conventional oxygen therapy for improving exercise capacity in FILD patients. METHODS We performed a prospective randomized controlled crossover trial with a high-intensity constant work-rate endurance test (CWRET) using HFNC (50 L/min, FiO2 0.5) and a venturi mask (VM) (15 L/min, FiO2 0.5) for oxygen delivery in FILD patients. The primary outcome variable was endurance time. The secondary outcome variables were SpO2, heart rate, Borg scale (dyspnea and leg fatigue), and patient's comfort. RESULTS Seven hundred and eleven patients were screened and 20 eligible patients were randomized. All patients completed the trial. The majority of patients were good responders to VM and HFNC compared with the baseline test (VM 75%; HFNC 65%). There was no significant difference in endurance time between HFNC and VM (HFNC 6.8 [95% CI 4.3-9.3] min vs VM 7.6 [95% CI 5.0-10.1] min, p = 0.669). No significant differences were found in other secondary endpoints. Subgroup analysis with HFNC good responders revealed that HFNC significantly extended the endurance time compared with VM (VM 6.4 [95%CI 4.5-8.3] min vs HFNC 7.8 [95%CI 5.8-9.7] min, p = 0.046), while no similar effect was observed in the VM good responders. CONCLUSIONS HFNC did not exceed the efficacy of VM on exercise capacity in FILD, but it may be beneficial if the settings match. Further large studies are needed to confirm these findings. TRIAL REGISTRATION UMIN-CTR: UMIN000021901.

中文翻译：

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高流量鼻插管氧疗对纤维化间质性肺病运动能力的影响：一项概念验证的随机对照试验。

背景技术患有纤维化间质性肺病（FILD）的患者经常会发生气体交换异常和通气受限，导致运动能力下降。高流量鼻插管（HFNC）氧气疗法是一种新型疗法，其生理有益作用已在各种临床环境中得到证明。我们假设HFNC氧疗在改善FILD患者运动能力方面可能优于常规氧疗。方法我们使用HFNC（50 L / min，FiO2 0.5）和文丘里面罩（VM）（15 L / min，FiO2 0.5）进行了一项高强度恒定工作耐力试验（CWRET）的前瞻性随机对照试验。用于FILD患者的氧气输送。主要结果变量是耐力时间。次要结果变量为SpO2，心率，博格量表（呼吸困难和腿部疲劳）以及患者的舒适度。结果筛选了711例患者，并对20例符合条件的患者进行了随机分组。所有患者均完成了试验。与基线测试相比，大多数患者对VM和HFNC的反应良好（VM 75％； HFNC 65％）。HFNC和VM之间的续航时间没有显着差异（HFNC 6.8 [95％CI 4.3-9.3] min vs VM 7.6 [95％CI 5.0-10.1] min，p = 0.669）。在其他次要终点没有发现显着差异。HFNC良好反应者的亚组分析显示，与VM相比，HFNC显着延长了耐力时间（VM 6.4 [95％CI 4.5-8.3] min vs HFNC 7.8 [95％CI 5.8-9.7] min，p = 0.046），但无相似之处在VM良好的响应者中观察到效果。结论HFNC并未超过VM对FILD运动能力的疗效，但如果设置匹配，则可能有益。需要进一步的大规模研究来证实这些发现。试用注册UMIN-CTR：UMIN000021901。