Visca Dina, Tsipouri Vicky, Mori Letizia, Firouzi Ashi, Fleming Sharon, Farquhar Morag, Leung Elizabeth, Maher Toby M, Cullinan Paul, Hopkinson Nick, Wells Athol U, Banya Winston, Whitty Jennifer A, Adamali Huzaifa, Spencer Lisa G, Sestini Piersante, Renzoni Elisabetta A
Interstitial Lung Disease Unit, Royal Brompton Hospital, Imperial College, London, UK.
NIHR Respiratory Biomedical Research Unit, Royal Brompton Hospital, Sydney Street, London, UK.
Trials. 2017 Apr 28;18(1):201. doi: 10.1186/s13063-017-1912-9.
Fibrotic interstitial lung diseases (ILDs) are chronic and often progressive conditions resulting in substantial morbidity and mortality. Shortness of breath, a symptom often linked to oxygen desaturation on exertion, is tightly linked to worsening quality of life in these patients. Although ambulatory oxygen is used empirically in their treatment, there are no ILD-specific guidelines on its use. To our knowledge, no studies are available on the effects of ambulatory oxygen on day-to-day life in patients with ILD.
METHODS/DESIGN: Ambulatory oxygen in fibrotic lung disease (AmbOx) is a multicentre, randomised controlled crossover trial (RCT) funded by the Research for Patient Benefit Programme of the National Institute for Health Research. The trial will compare ambulatory oxygen used during daily activities with no ambulatory oxygen in patients with fibrotic lung disease whose oxygen saturation (SaO) is ≥94% at rest, but drops to ≤88% on a 6-min Walk Test. The randomised controlled trial (RCT) will evaluate the effects on health status (measured by the King's Brief ILD Questionnaire: K-BILD) of ambulatory oxygen used at home, at an optimal flow rate determined by titration at screening visit, and administered for a 2-week period, compared to 2 weeks off oxygen. Key secondary outcomes will include breathlessness on activity scores, as measured by the University of California San Diego Shortness of Breath Questionnaire, global patient assessment of change scores, as well as quality of life scores (St George's Respiratory Questionnaire), anxiety and depression scores (Hospital Anxiety and Depression Scale), activity markers measured by SenseWear Armbands, pulse oximetry measurements, patient-reported daily activities, patient- and oxygen company-reported oxygen cylinder use. The study also includes a qualitative component and will explore in interviews patients' experiences of the use of a portable oxygen supply and trial participation in a subgroup of 20 patients and carers.
This is the first RCT of the effects of ambulatory oxygen during daily life on health status and breathlessness in fibrotic lung disease. The results generated should provide the basis for setting up ILD-specific guidelines for the use of ambulatory oxygen.
National Clinical Trials Registry, identifier: NCT02286063 . Registered on 8 October 2014 (retrospectively registered).
纤维化间质性肺疾病（ILDs）是慢性疾病，且往往呈进行性发展，会导致严重的发病率和死亡率。气短这一症状通常与运动时的氧饱和度下降有关，与这些患者生活质量的恶化密切相关。尽管在其治疗中经验性地使用了家庭氧疗，但尚无关于ILDs患者使用家庭氧疗的特异性指南。据我们所知，尚无关于家庭氧疗对ILDs患者日常生活影响的研究。
方法/设计：纤维化肺病家庭氧疗（AmbOx）研究是一项多中心、随机对照交叉试验（RCT），由英国国家卫生研究院患者受益研究计划资助。该试验将比较日常活动中使用家庭氧疗与不使用家庭氧疗对纤维化肺病患者的影响，这些患者静息时氧饱和度（SaO）≥94%，但在6分钟步行试验中降至≤88%。该随机对照试验（RCT）将评估在筛查访视时通过滴定法确定的最佳流速下，在家中使用家庭氧疗2周与停用氧疗2周相比，对健康状况（通过国王简短ILD问卷：K-BILD测量）的影响。主要次要结局将包括活动时气短评分（通过加利福尼亚大学圣地亚哥分校气短问卷测量）、患者整体评估的变化评分、生活质量评分（圣乔治呼吸问卷）、焦虑和抑郁评分（医院焦虑和抑郁量表）、通过SenseWear臂带测量的活动指标、脉搏血氧饱和度测量、患者报告的日常活动、患者和氧气供应商报告的氧气瓶使用情况。该研究还包括一个定性部分，将对20名患者及其护理人员组成的亚组进行访谈，探讨患者使用便携式氧气供应的体验和试验参与情况。
这是第一项关于日常生活中家庭氧疗对纤维化肺病患者健康状况和气短影响的随机对照试验。所产生的结果应为制定ILDs患者家庭氧疗的特异性指南提供依据。
美国国立医学图书馆临床试验注册库，标识符：NCT02286063。于2014年10月8日注册（追溯注册）。
