UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034572