UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038005 |
|---|---|
| Receipt number | R000043170 |
| Scientific Title | efficasy of oxygen-conserving devices with a built-in reservoir tank in patients with interstitial lung diseaes. |
| Date of disclosure of the study information | 2019/09/30 |
| Last modified on | 2023/11/22 19:41:09 |
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Basic information
Public title
efficasy of oxygen-conserving devices with a built-in reservoir tank in patients with interstitial lung diseaes.
Acronym
efficasy of oxygen-conserving devices with a built-in reservoir tank in patients with interstitial lung diseaes.
Scientific Title
efficasy of oxygen-conserving devices with a built-in reservoir tank in patients with interstitial lung diseaes.
Scientific Title:Acronym
efficasy of oxygen-conserving devices with a built-in reservoir tank in patients with interstitial lung diseaes.
Region
| Japan |
Condition
Condition
interstitial lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficasy of oxygen-conserving devices with a built-in reservoir tank
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change of SpO2 from baseline during exercise test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
oxygen-conserving devices with a built-in reservoir tank
Interventions/Control_2
oxygen-conserving devices without a built-in reservoir tank
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with idiopathic interstitial pneumonia.
SpO2<90 during exercise
Key exclusion criteria
PaO2<60 Torr at rest
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Nishioka |
Organization
Graduate School of Biomedical Sciences,
Tokushima University
Division name
Department of Respiratory Medicine and Rheumatology
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
+81-88-633-7126
yasuhiko@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | satoshi |
| Middle name | |
| Last name | sakaguchi |
Organization
Graduate School of Biomedical Sciences, Tokushima University
Division name
Department of Respiratory Medicine and Rheumatology
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
+81-88-633-7126
Homepage URL
sakaguchi.satoshi@tokushima-u.ac.jp
Sponsor or person
Institute
Graduate School of Biomedical Sciences, Tokushima University
Department of Respiratory Medicine and Rheumatology
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Biomedical Sciences, Tokushima University
Department of Respiratory Medicine and Rheumatology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima University
Address
2-50-1 Kuramoto-cho, Tokushima
Tel
088-633-9294
awachiken@tokushima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 30 | Day |
Related information
URL releasing protocol
not release
Publication of results
Unpublished
Result
URL related to results and publications
now writing
Number of participants that the trial has enrolled
10
Results
The degree of SpO2 reduction was significantly and consistently lower during exercise with OxyCube than comparison to exercise with the sham device, and the difference in SpO2 during exercise was greatest at the 6-minute mark (6.0 +- 3.0%, 9.7 +- 3.0%, respectively; P < 0.001). The HR and BS did not differ between the two devices, indicating the quantitative nature of this study.
Results date posted
| 2023 | Year | 11 | Month | 22 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Because I was not able to work on the paper submission.
Date of the first journal publication of results
Baseline Characteristics
Thirteen patients were enrolled in this study between September 2019 and December 2020. One participant was excluded due to withdrawal of consent. Two additional patients were excluded from the study because their minimum SpO2 levels remained over 90 after CPET. Of the 10 patients who participated in the study, 1 was excluded because of a lack of observable SpO2 changes during each exercise test on an ergometer. Consequently, 9 patients were included in the final analysis
One patient presented with scleroderma-related interstitial lung disease (SSc-ILD), whereas the other was diagnosed with asbestosis.
Participant flow
Thirteen patients were enrolled in this study between September 2019 and December 2020.
Adverse events
no
Outcome measures
The primary endpoint was the change in SpO2 from the baseline . The secondary endpoints were the change in HR from the baseline and change in BS from the baseline .
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 13 | Day |
Last modified on
| 2023 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043170
