Portable low-flow nasal oxygen versus ambient air in patients with chronic lung disease and exercise-induced hypoxaemia: a randomised controlled crossover non-inferiority trial.

IF 4 3区 医学 Q1 RESPIRATORY SYSTEM
Mona Lichtblau, Carmen Wick, Anna Titz, Julian Müller, Simon Raphael Schneider, Dinah Hertig, Zoe Bousraou, Alessandro Vella, Michael Furian, Malcolm Kohler, Esther Irene Schwarz, Silvia Ulrich
{"title":"Portable low-flow nasal oxygen versus ambient air in patients with chronic lung disease and exercise-induced hypoxaemia: a randomised controlled crossover non-inferiority trial.","authors":"Mona Lichtblau, Carmen Wick, Anna Titz, Julian Müller, Simon Raphael Schneider, Dinah Hertig, Zoe Bousraou, Alessandro Vella, Michael Furian, Malcolm Kohler, Esther Irene Schwarz, Silvia Ulrich","doi":"10.1136/bmjresp-2025-004048","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Exercise-induced desaturation is a common symptom in chronic lung disease (CLD) and is associated with functional limitation and increased mortality. Although portable low-flow supplemental oxygen therapy (SOT) is commonly prescribed for exercise-induced hypoxaemia, evidence for SOT to improve performance is inconsistent.</p><p><strong>Method: </strong>This pragmatic, randomised, controlled, non-inferiority crossover trial enrolled patients with chronic obstructive pulmonary and interstitial lung disease who exhibited exercise-induced oxygen desaturation of >3%. Each patient performed two 6-minute walk distance (6MWD) tests in randomised order: one breathing ambient air and one using low-flow SOT delivered by a portable backpack concentrator (1-2 L/min). The primary outcome was 6MWD, secondary outcomes included perceived exertion and preference of the interventions. A predefined non-inferiority margin of 35 m was used.</p><p><strong>Results: </strong>Forty patients were enrolled (mean age 66±13 years; 14 women; 20 with chronic obstructive pulmonary disease (COPD), 20 with interstitial lung disease (ILD)). The mean difference in 6MWD between ambient air and SOT was 0 m (95% CI -14 to 13 m; p<0.001 for non-inferiority). Secondary outcomes demonstrated significantly lower dyspnoea scores with SOT both overall and within COPD/ILD subgroups. Patient preferences were split, with 49% favouring ambient air and 51% preferring SOT. A clinically meaningful improvement in 6MWD of >35 m was found in five patients.</p><p><strong>Conclusion: </strong>In patients with CLD and exercise-induced desaturation, ambient air was non-inferior to pulsed low-dose SOT by portable concentrator in 6MWD, but SOT improved dyspnoea. These findings highlight the need for more effective, patient-acceptable oxygen delivery systems and further research to identify responders to SOT.</p><p><strong>Trial registration number: </strong>NCT06385301.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"13 1","pages":""},"PeriodicalIF":4.0000,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13599829/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMJ Open Respiratory Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/bmjresp-2025-004048","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"RESPIRATORY SYSTEM","Score":null,"Total":0}
引用次数: 0

Abstract

Background: Exercise-induced desaturation is a common symptom in chronic lung disease (CLD) and is associated with functional limitation and increased mortality. Although portable low-flow supplemental oxygen therapy (SOT) is commonly prescribed for exercise-induced hypoxaemia, evidence for SOT to improve performance is inconsistent.

Method: This pragmatic, randomised, controlled, non-inferiority crossover trial enrolled patients with chronic obstructive pulmonary and interstitial lung disease who exhibited exercise-induced oxygen desaturation of >3%. Each patient performed two 6-minute walk distance (6MWD) tests in randomised order: one breathing ambient air and one using low-flow SOT delivered by a portable backpack concentrator (1-2 L/min). The primary outcome was 6MWD, secondary outcomes included perceived exertion and preference of the interventions. A predefined non-inferiority margin of 35 m was used.

Results: Forty patients were enrolled (mean age 66±13 years; 14 women; 20 with chronic obstructive pulmonary disease (COPD), 20 with interstitial lung disease (ILD)). The mean difference in 6MWD between ambient air and SOT was 0 m (95% CI -14 to 13 m; p<0.001 for non-inferiority). Secondary outcomes demonstrated significantly lower dyspnoea scores with SOT both overall and within COPD/ILD subgroups. Patient preferences were split, with 49% favouring ambient air and 51% preferring SOT. A clinically meaningful improvement in 6MWD of >35 m was found in five patients.

Conclusion: In patients with CLD and exercise-induced desaturation, ambient air was non-inferior to pulsed low-dose SOT by portable concentrator in 6MWD, but SOT improved dyspnoea. These findings highlight the need for more effective, patient-acceptable oxygen delivery systems and further research to identify responders to SOT.

Trial registration number: NCT06385301.

便携式低流量鼻氧与环境空气在慢性肺病和运动性低氧血症患者中的比较:一项随机对照交叉非劣效性试验
背景:运动诱导的去饱和是慢性肺部疾病(CLD)的常见症状,与功能限制和死亡率增加有关。尽管便携式低流量补充氧疗法(SOT)通常用于治疗运动引起的低氧血症,但SOT改善运动表现的证据并不一致。方法:这项实用、随机、对照、非低效性的交叉试验纳入了慢性阻塞性肺和间质性肺疾病患者,这些患者表现出运动引起的氧饱和度为bbbb3 %。每位患者按随机顺序进行两次6分钟步行距离(6MWD)测试:一次呼吸环境空气,另一次使用便携式背包浓缩器输送的低流量SOT(1-2升/分钟)。主要结局是6MWD,次要结局包括感知劳累和干预偏好。预定义的非劣效裕度为35 m。结果:共纳入40例患者(平均年龄66±13岁;女性14例;慢性阻塞性肺疾病(COPD) 20例,间质性肺疾病(ILD) 20例)。环境空气与SOT之间6MWD的平均差异为0 m (95% CI -14 ~ 13 m); 5例患者发现p35 m。结论:在CLD合并运动性去饱和的患者中,6MWD时环境空气不低于便携式浓缩器脉冲低剂量SOT,但SOT改善了呼吸困难。这些发现强调需要更有效的、患者可接受的氧气输送系统,并进一步研究确定SOT的应答者。试验注册号:NCT06385301。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
BMJ Open Respiratory Research
BMJ Open Respiratory Research RESPIRATORY SYSTEM-
CiteScore
6.60
自引率
2.40%
发文量
95
审稿时长
12 weeks
期刊介绍: BMJ Open Respiratory Research is a peer-reviewed, open access journal publishing respiratory and critical care medicine. It is the sister journal to Thorax and co-owned by the British Thoracic Society and BMJ. The journal focuses on robustness of methodology and scientific rigour with less emphasis on novelty or perceived impact. BMJ Open Respiratory Research operates a rapid review process, with continuous publication online, ensuring timely, up-to-date research is available worldwide. The journal publishes review articles and all research study types: Basic science including laboratory based experiments and animal models, Pilot studies or proof of concept, Observational studies, Study protocols, Registries, Clinical trials from phase I to multicentre randomised clinical trials, Systematic reviews and meta-analyses.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信
小红书