Unique ID issued by UMIN | UMIN000005098 |
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Receipt number | R000006057 |
Scientific Title | A randomized trial of ambulatory oxygen in patients with idiopathic pulmonary fibrosis and desaturation but without resting hypoxemia |
Date of disclosure of the study information | 2011/02/18 |
Last modified on | 2014/12/18 12:29:44 |
A randomized trial of ambulatory oxygen in patients with idiopathic pulmonary fibrosis and desaturation but without resting hypoxemia
ambulatory oxygen in patients with IPF and desaturation but without resting hypoxemia
A randomized trial of ambulatory oxygen in patients with idiopathic pulmonary fibrosis and desaturation but without resting hypoxemia
ambulatory oxygen in patients with IPF and desaturation but without resting hypoxemia
Japan |
idiopathic pulmonary fibrosis
Pneumology |
Others
NO
To evaluate the short-term effect of ambulatory oxygen in patients with IPF and desaturation but without resting hypoxemia.
Efficacy
Confirmatory
dyspnea after 6-min walk
O2 saturation after 6-min walk
6-min walk distance
fatigue after 6-min walk
heart rate after 6-min walk
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Other |
ambulatory oxygen
ambulatory air
20 | years-old | <= |
Not applicable |
Male and Female
1) patients with idiopathic pulmonary fibrosis diagnosed with ATS/ERS/JRS guideline 2011
2) resting PaO2 >=60mmHg and < 80mmHg
3) desaturation (SpO2 <88%) on 6-min walk
4) without any infection and acute exacerbation within preceding 3 mo
5) written informed consent
1) patients with uncontrolled comorbidities
2) patients who cannot undergo pulmonary function test and/or 6-min walk test
20
1st name | |
Middle name | |
Last name | Osamu Nishiyama |
Kinki University School of Medicine
Department of Respiratory Medicine and Allergology
377-2 Onohigashi, Osaka-sayama, Osaka, Japan
072-366-0221
nishi-o@med.kindai.ac.jp
1st name | |
Middle name | |
Last name | Osamu Nishiyama |
Kinki University School of Medicine
Department of Respiratory Medicine and Allergology
377-2 Onohigashi, Osaka-sayama, Osaka, Japan
072-366-0221
nishi-o@med.kindai.ac.jp
Department of Respiratory Medicine and Allergology, Kinki University School of Medicine
None
Self funding
NO
近畿大学医学部(大阪府)
2011 | Year | 02 | Month | 18 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/23806287
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) mm Hg 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.
Completed
2010 | Year | 11 | Month | 11 | Day |
2011 | Year | 02 | Month | 01 | Day |
2012 | Year | 05 | Month | 01 | Day |
2012 | Year | 05 | Month | 01 | Day |
2012 | Year | 05 | Month | 01 | Day |
2011 | Year | 02 | Month | 16 | Day |
2014 | Year | 12 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006057
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