BACKGROUND Despite a lack of evidence, ambulatory oxygen therapy is frequently prescribed for patients with interstitial lung disease (ILD) and exertional desaturation. Patients often prefer portable oxygen concentrators to oxygen cylinders. This study aimed to examine the feasibility of conducting a clinical trial of ambulatory oxygen delivered via portable concentrators in patients with ILD. METHODS In this randomised, triple-blinded, sham-controlled trial, 30 participants with ILD and isolated exertional desaturation to <90% on 6-minute walk tests were randomised to 12-week ambulatory oxygen or air delivered via portable concentrators, with assessments performed at baseline and Weeks 4, 12 and 18. Primary outcomes were trial feasibility and the change in 6-minute walk distance (6MWD) on room air at Week 12. FINDINGS Study recruitment was completed within 18 months, with six withdrawals. Participant blinding was successful, with the Bang's Blinding Index being 0 (95% CI -0.40, 0.40) for the oxygen group and 0 (-0.42, 0.42) for the sham group. There was no significant difference in 6MWD between groups at Week 12 (mean difference of -34m [95% CI: -105, 36], p = 0.34). For secondary outcomes, compared to the sham group, the oxygen group had a significantly higher Leicester Cough Questionnaire psychological domain score, indicating better cough-related quality of life (mean difference of 0.9 [95% CI: 0.2, 1.6], p = 0.01), but a shorter duration of moderate-to-vigorous activities (mean difference of -135 [95% CI: -267, -3], p = 0.04) at Week 12. CONCLUSION Based on the results of this pilot study, a definitive randomised controlled trial with a longer intervention duration is warranted to clarify therapeutic impacts of ambulatory oxygen in patients with ILD.

中文翻译：

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纤维化 ILD 中的动态氧气：一项试点、随机、三盲、假对照试验

背景尽管缺乏证据，但经常为患有间质性肺病 (ILD) 和劳力性去饱和的患者开具动态氧疗。与氧气瓶相比，患者通常更喜欢便携式制氧机。本研究旨在检查对 ILD 患者通过便携式浓缩器输送动态氧气进行临床试验的可行性。方法 在这项随机、三盲、假对照试验中，30 名 ILD 和孤立的劳力性去饱和在 6 分钟步行测试中<90% 的参与者被随机分配接受 12 周动态氧气或通过便携式浓缩器输送的空气，并进行评估在基线和第 4、12 和 18 周。主要结果是试验可行性和第 12 周室内空气中 6 分钟步行距离 (6MWD) 的变化。结果 研究招募在 18 个月内完成，有 6 次退出。参与者盲法成功，氧组的 Bang 盲指数为 0 (95% CI -0.40, 0.40)，假手术组为 0 (-0.42, 0.42)。第 12 周时，组间 6MWD 没有显着差异（平均差异为 -34m [95% CI：-105, 36]，p = 0.34）。对于次要结果，与假手术组相比，氧气组的莱斯特咳嗽问卷心理领域得分显着更高，表明咳嗽相关的生活质量更好（平均差异为 0.9 [95% CI: 0.2, 1.6]，p = 0.01 )，但在第 12 周时中度至剧烈活动的持续时间较短（平均差异为 -135 [95% CI：-267，-3]，p = 0.04）。 结论 基于该试点研究的结果，