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

Visca, Dina, Tsipouri, Vicky, Mori, Letizia, Firouzi, Ashi, Fleming, Sharon, Farquhar, Morag ORCID: https://orcid.org/0000-0001-7991-7679, Leung, Elizabeth, Maher, Toby M., Cullinan, Paul, Hopkinson, Nick, Wells, Athol U., Banya, Winston, Whitty, Jennifer A. ORCID: https://orcid.org/0000-0002-5886-1933, Adamali, Huzaifa, Spencer, Lisa G., Sestini, Piersante and Renzoni, Elisabetta A. (2017) Ambulatory oxygen in fibrotic lung disease (AmbOx): study protocol for a randomised controlled trial. Trials, 18 (1). ISSN 1745-6215

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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.

Item Type: Article
Uncontrolled Keywords: fibrotic interstitial lung disease,ambulatory oxygen,oxygen desaturation,health status,quality of life,activity measures,shortness of breath
Faculty \ School: Faculty of Medicine and Health Sciences > School of Health Sciences
Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Groups > Health Economics
Faculty of Medicine and Health Sciences > Research Groups > Health Promotion
Faculty of Medicine and Health Sciences > Research Groups > Respiratory and Airways Group
Faculty of Medicine and Health Sciences > Research Groups > Health Services and Primary Care
Faculty of Medicine and Health Sciences > Research Groups > Public Health and Health Services Research (former - to 2023)
Faculty of Medicine and Health Sciences > Research Centres > Lifespan Health
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Depositing User: Pure Connector
Date Deposited: 03 May 2017 05:10
Last Modified: 19 Oct 2023 01:58
URI: https://ueaeprints.uea.ac.uk/id/eprint/63353
DOI: 10.1186/s13063-017-1912-9

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