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Ambulatory oxygen in fibrotic lung disease (AmbOx): study protocol for a randomised controlled trial

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Title: Ambulatory oxygen in fibrotic lung disease (AmbOx): study protocol for a randomised controlled trial
Authors: Visca, D
Tsipouri, V
Mori, L
Firouzi, A
Fleming, S
Farquhar, M
Leung, E
Maher, TM
Cullinan, P
Hopkinson, N
Wells, AU
Banya, W
Whitty, JA
Adamali, H
Spencer, LG
Sestini, P
Renzoni, EA
Item Type: Journal Article
Abstract: Background: 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 (SaO2) 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. Discussion: 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.
Issue Date: 28-Apr-2017
Date of Acceptance: 22-Mar-2017
URI: http://hdl.handle.net/10044/1/48645
DOI: https://dx.doi.org/10.1186/s13063-017-1912-9
ISSN: 1745-6215
Publisher: BIOMED CENTRAL LTD
Journal / Book Title: TRIALS
Volume: 18
Issue: 1
Copyright Statement: © 2017 The Author(s). Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Sponsor/Funder: NIHR Research for Patient Benefit Programme
Funder's Grant Number: PB-PG-0712-28073
Keywords: Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Research & Experimental Medicine
Fibrotic interstitial lung disease
Ambulatory oxygen
Oxygen desaturation
Health status
Quality of life
Activity measures
Shortness of breath
IDIOPATHIC PULMONARY-FIBROSIS
INTERSTITIAL PNEUMONIA
IMPORTANT DIFFERENCE
PHYSICAL-ACTIVITY
ACTIVITY DIARY
6-MINUTE WALK
HEALTH-STATUS
K-BILD
QUESTIONNAIRE
VALIDATION
General & Internal Medicine
1102 Cardiovascular Medicine And Haematology
1103 Clinical Sciences
Publication Status: Published
Article Number: ARTN 201
Appears in Collections:Division of Surgery
National Heart and Lung Institute
Airway Disease
Division of Cancer
Faculty of Medicine



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