UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034568
Receipt number R000039410
Scientific Title The significance of transcutaneous continuous overnight carbon-dioxide trends in COPD (chronic obstructive pulmonary disease) stages
Date of disclosure of the study information 2018/10/19
Last modified on 2020/04/20 13:14:52

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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 or person

Institute

Kyoto Prefectural University of Medicine, Department of Respiratory 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039410


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name