UMIN-CTR Clinical Trial

Basic information
Public title	The significance of transcutaneous continuous overnight carbon-dioxide trends in COPD (chronic obstructive pulmonary disease) stages
Acronym	The significance of transcutaneous continuous overnight CO2 trends in COPD stages
Scientific Title	The significance of transcutaneous continuous overnight carbon-dioxide trends in COPD (chronic obstructive pulmonary disease) stages
Scientific Title:Acronym	The significance of transcutaneous continuous overnight CO2 trends in COPD stages
Region	Japan

Condition
Condition	COPD(chronic obstructive pulmonary disease)
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To grasp transcutaneous continuous overnight carbon-dioxide trends on GOLD stages of COPD patients.
Basic objectives2	Others
Basic objectives -Others	The measurement of the CO2 concentration in the arterial blood is also accompanied by pain associated with blood test, frequent measurement is not practical. Transcutaneous CO2 monitor has been developed in recent years. We investigate whether the severity in the pulmonary function test of COPD, well-known as GOLD, is correlated to the CO2 concentration using transcutaneous CO2 monitor.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ratio of more than 55 mmHg of transcutaneous continuous overnight carbon-dioxide trends on GOLD stages of COPD patients.
Key secondary outcomes	CAT:The chronic obstructive pulmonary disease Assessment Test questionnaire, EXACT(EXAcerbations of Chronic pulmonary disease Tool), ER-S score(EXACT-Respiratory Symptoms scale), COPD exacerbation frequency

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	The patients who have diagnosed COPD by obstruction disorder by lung function examination, chest CT or X-ray examination, and interview.
Key exclusion criteria	The patients who cannot exclude obstructive pulmonary disorders other than COPD, and those who do not agree to participate in the study.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Nobuyo Middle name Last name Tamiya
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Respiratory medicine
Zip code	6028566
Address	465 Kajii-cho Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5513
Email	koma@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Nobuyo Middle name Last name Tamiya
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Respiratory medicine
Zip code	6028566
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5513
Homepage URL
Email	koma@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine, Department of Respiratory medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Japanese Red Cross Society Kyoto Daini Hospital Rakuwakai Otowa Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Kyoto Prefectural University of Medicine
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
Tel	075-251-5337
Email	rinri@koto.kpu-m.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	京都府立医科大学附属病院（京都府）、京都第二赤十字病院（京都府）、洛和会音羽病院（京都府）

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 19 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	No longer recruiting
Date of protocol fixation	2018 Year 10 Month 19 Day
Date of IRB	2018 Year 11 Month 19 Day
Anticipated trial start date	2018 Year 10 Month 19 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
Date analysis concluded

Other
Other related information	To investigate whether CO2 concentration using the transcutaneous CO2 monitor trend is correlated to COPD severity.

Management information
Registered date	2018 Year 10 Month 19 Day
Last modified on	2020 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039410