Objective Effects and Patient Preferences for Ambulatory Oxygen in Fibrotic Interstitial Lung Disease With Isolated Exertional Hypoxaemia: A Placebo-Controlled 6-Minute Walk Test Study.

IF 6.6 2区 医学 Q1 RESPIRATORY SYSTEM
Respirology Pub Date : 2025-03-11 DOI:10.1111/resp.70020
Giuseppina Ciarleglio, Paolo Cameli, David Bennett, Behar Cekorja, Paola Rottoli, Elisabetta A Renzoni, Piersante Sestini, Elena Bargagli
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引用次数: 0

Abstract

Background and objective: The available evidence on the effects of ambulatory oxygen on exercise impairment in patients with fibrotic interstitial lung diseases (F-ILD) is of limited quality.

Methods: We conducted a randomised, double-blind, placebo-controlled crossover trial with 32 normoxaemic F-ILD patients, desaturating to ≤ 88% during a baseline 6-minute walk test (6MWT) on ambient air. After determining the oxygen flow needed to prevent desaturation, patients completed two double-blind 6MWTs with either oxygen or placebo (compressed medical air) at the same personalised flow. Objective measures included oxygen saturation, pulse rate, and distance walked. Patient-reported outcomes, assessed via visual analogue scales, included end-of-test dyspnoea, fatigue, and preferences for walking with oxygen or placebo versus each other and ambient air.

Results: Ambulatory oxygen, compared to placebo, prevented desaturation, reduced tachycardia, increased walking distance by 37 m (95% CI: 10-74, p = 0.008), and lessened dyspnoea and fatigue. The mean preference score for oxygen over placebo was 2.6 (95% CI: 1.9-3.2, p < 0.0005), significantly greater than equivalence. The preference score for placebo over ambient air was -1.5 (-2.4 to 0.64, p = 0.005), significantly lower than equivalence, while the score for oxygen over ambient air was 0.4 (-0.7 to 1.5), not significantly different from equivalence.

Conclusions: Our data confirm that ambulatory oxygen provides significant benefits beyond a placebo effect; although in some patients it is associated with a negative perception that may hinder treatment acceptance. This strengthens the evidence supporting current recommendations and suggests that incorporating patient preferences recorded at the time of the 6MWT into clinical discussions can aid shared decision making regarding ambulatory oxygen.

Trial registration: ClinicalTrials.gov identifier: NCT02668029.

目的:纤维化间质性肺疾病伴孤立性运动性低氧血症患者动态氧的影响和患者偏好:一项安慰剂对照6分钟步行试验研究。
背景与目的:关于动态供氧对纤维化间质性肺疾病(F-ILD)患者运动障碍影响的现有证据质量有限。方法:我们对32例等氧血症F-ILD患者进行了随机、双盲、安慰剂对照交叉试验,这些患者在环境空气中进行基线6分钟步行测试(6MWT)时去饱和至≤88%。在确定防止去饱和所需的氧流量后,患者以相同的个性化流量使用氧气或安慰剂(压缩医用空气)完成两次双盲6MWTs。客观测量包括血氧饱和度、脉搏率和步行距离。通过视觉模拟量表评估患者报告的结果,包括试验结束时呼吸困难、疲劳以及对氧气或安慰剂与环境空气相比行走的偏好。结果:与安慰剂相比,动态供氧可防止去饱和,减少心动过速,使步行距离增加37米(95% CI: 10-74, p = 0.008),并减轻呼吸困难和疲劳。氧气比安慰剂的平均偏好评分为2.6 (95% CI: 1.9-3.2, p)。结论:我们的数据证实,动态氧气比安慰剂效应提供了显著的益处;尽管在一些患者中,它与可能阻碍治疗接受的负面看法有关。这加强了支持当前建议的证据,并表明将6MWT时记录的患者偏好纳入临床讨论可以帮助共同制定关于动态氧气的决策。试验注册:ClinicalTrials.gov标识符:NCT02668029。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Respirology
Respirology 医学-呼吸系统
CiteScore
10.60
自引率
5.80%
发文量
225
审稿时长
1 months
期刊介绍: Respirology is a journal of international standing, publishing peer-reviewed articles of scientific excellence in clinical and clinically-relevant experimental respiratory biology and disease. Fields of research include immunology, intensive and critical care, epidemiology, cell and molecular biology, pathology, pharmacology, physiology, paediatric respiratory medicine, clinical trials, interventional pulmonology and thoracic surgery. The Journal aims to encourage the international exchange of results and publishes papers in the following categories: Original Articles, Editorials, Reviews, and Correspondences. Respirology is the preferred journal of the Thoracic Society of Australia and New Zealand, has been adopted as the preferred English journal of the Japanese Respiratory Society and the Taiwan Society of Pulmonary and Critical Care Medicine and is an official journal of the World Association for Bronchology and Interventional Pulmonology.
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