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Effect of ambulatory oxygen on exertional dyspnea in IPF patients without resting hypoxemia |
Nishiyama O, Miyajima H, Fukai Y, Yamazaki R, Satoh R, Yamagata T, Sano H, Iwanaga T, Higashimoto Y, Nakajima H, Kume H, Tohda Y |
Respiratory Medicine 2013 Aug;107(8):1241-1246 |
clinical trial |
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: Yes; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND AND OBJECTIVE: The effects of ambulatory oxygen for idiopathic pulmonary fibrosis (IPF) patients without resting hypoxemia have not been elucidated. The purpose of this study was to assess the effect of ambulatory oxygen on dyspnea in IPF patients without resting hypoxemia but with desaturation on exertion. METHODS: This was a double-blind, placebo-controlled, randomized crossover trial of ambulatory oxygen versus ambulatory air. Patients with IPF who had a partial pressure of arterial oxygen (PaO2) between 60 mmHg and 80 mmHg at rest, and desaturation of 88% or less in a room-air 6-min walk test were eligible. Patients underwent a standardized 6-min walk test and a 6-min free walk test under each ambulatory gas. Oxygen and air were provided at 4 L/min intranasally. Dyspnea was evaluated immediately, 1, and 2 min after the tests. RESULTS: Twenty patients (16 men), with a mean age of 73.5 (SD 4.1) years, % predicted forced vital capacity (FVC) of 71.0% (13.3), % predicted diffusion capacity for carbon monoxide (DLco) of 57.0% (13.3), and PaO2 of 72.5 (5.4) mmHg were recruited. No significant differences in dyspnea were observed between ambulatory oxygen and air at each time point. However, some patients showed improvement in dyspnea with oxygen on an individual basis. CONCLUSIONS: Since oxygen provides no additional benefit over air in terms of exertional dyspnea for IPF patients without resting hypoxemia, routine prescription of ambulatory oxygen is not recommended. However, assessment on an individual basis is necessary. TRIAL REGISTRATION: UMIN Clinical Trial Registry; number UMIN000005098; URL http://www.umin.ac.jp/ctr/.
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