UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047507 |
|---|---|
| Receipt number | R000052985 |
| Scientific Title | Establish of monitoring transcutaneous CO2 during rehabilitation of COPD patients with O2 inhalation |
| Date of disclosure of the study information | 2022/04/17 |
| Last modified on | 2025/04/19 11:41:14 |
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Basic information
Public title
Efficacy of rehabilitation training with HFNC for COPD patients under 2-concentration oxygen inhalation: Establishment of a percutaneous monitoring method for carbon dioxide accumulation.
Acronym
ROCM
Scientific Title
Establish of monitoring transcutaneous CO2 during rehabilitation of COPD patients with O2 inhalation
Scientific Title:Acronym
ROCM (Rehabilitation with O2 with CO2 monitoring)
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
COPD patients suffer from dyspnea on exercise and rehabilitation is sometimes shortly stopped. Adding O2 inhalation and CO2 monitoring, we try to establish a safe method of rehabilitation for COPD patients avoiding CO2 retention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Six minutes walk test after 1-2 months
Key secondary outcomes
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Usual respiration rehabilitation once a week, for 1 months. Then respiration rehabilitation with O2 inhalation FIO2 0.3 using HFNC, once a week, for 2 months. After washing out for 3 months, cross-over.
Interventions/Control_2
Usual respiration rehabilitation once a week, for 1 months. Then respiration rehabilitation with O2 inhalation FIO2 0.5 using HFNC, once a week, for 2 months. After washing out for 3 months, cross-over.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
COPD patients suffering dyspnea on exercise
Key exclusion criteria
In case subjects rejected rehabilitation
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Umeda |
Organization
International University of Health and Welfare
Division name
Department of General Medicine, School of Medicine (Shioya Hospital)
Zip code
329-2145
Address
Tomita 77, Yaita-City, Tochigi
TEL
0287441155
umeda@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Umeda |
Organization
International University of Health and Welfare
Division name
Department of General Medicine, School of Medicine (Shioya Hospital)
Zip code
329-2145
Address
Tomita 77, Yaita-City, Tochigi, Japan
TEL
0287441155
Homepage URL
umeda@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare Shioya Hospital
Address
Tomita 77, Yaita-City, Tochigi Prefecture
Tel
0287441155
umeda@iuhw.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 17 | Day |
Last modified on
| 2025 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052985
