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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030272
Receipt No. 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 2017/12/05

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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
Email 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
Email D16009@hama-med.ac.jp

Sponsor
Institute Department of Clinical pharmacology and therapeutics, Hamamatsu University school of medicine
Institute
Department

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
Email

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
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
2017 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034572

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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