UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030272 |
|---|---|
| Receipt number | R000034572 |
| Scientific Title | Measurement of peripheral capillary hemoglobin oxygen saturation during activities of daily living in patients with chronic pulmonary disease. |
| Date of disclosure of the study information | 2017/12/05 |
| Last modified on | 2019/12/15 09:43:09 |
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Basic information
Public title
Measurement of peripheral capillary hemoglobin oxygen saturation during activities of daily living in patients with chronic pulmonary disease.
Acronym
Measurement of SpO2 during activities of daily living in patients with chronic pulmonary disease.
Scientific Title
Measurement of peripheral capillary hemoglobin oxygen saturation during activities of daily living in patients with chronic pulmonary disease.
Scientific Title:Acronym
Measurement of SpO2 during activities of daily living in patients with chronic pulmonary disease.
Region
| Japan |
Condition
Condition
Chronic pulmonary disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to measure continuously peripheral capillary hemoglobin oxygen saturation (SpO2) during having a shower bath, and to compare the resting and showering SpO2 profiles.
Basic objectives2
Others
Basic objectives -Others
To ascertain that SpO2 decrease during having the shower bath.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of the SpO2 values at rest and during having the shower bath.
Key secondary outcomes
Comparison of the feeling of dyspnea at rest and during having the shower bath.
Comparison of the SpO2 values during having the shower bath and 6 minutes walk test (6MWT).
Comparison of the feeling of dyspnea during having the shower bath and 6MWT.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wearing a pulse oximeter during having the shower bath.
Interventions/Control_2
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
1. The treatment of acute period has been completed.
2. 20 years and over.
3. Male and female
4. Respiratory disease patients with receiving home oxygen therapy or showing oxygen desaturation during effort.
5. Respiratory disease patients with giving a written informed consent.
6. Respiratory disease patients with being able to wear the pulse oximeter by themselves or helper.
Key exclusion criteria
1. Respiratory disease patients who cannot manipulate a measurement device.
2. Inappropriate patients due to other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Watanabe |
Organization
Hamamatsu University school of medicine
Division name
Department of Clinical pharmacology and therapeutics
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan 431-3192
TEL
053-435-2385
hwat@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryugo Sakurada |
Organization
Hamamatsu University school of medicine
Division name
Department of Clinical pharmacology and therapeutics
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan 431-3192
TEL
053-435-2385
Homepage URL
D16009@hama-med.ac.jp
Sponsor or person
Institute
Department of Clinical pharmacology and therapeutics, Hamamatsu University school of medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
磐田市立総合病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2017 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 05 | Day |
Last modified on
| 2019 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034572
