UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029222 |
|---|---|
| Receipt number | R000033402 |
| Scientific Title | The study of the relationship between oxygen dose at night and arterial partial pressure of carbon dioxide in type 2 chronic respiratory failure patients |
| Date of disclosure of the study information | 2017/09/20 |
| Last modified on | 2024/03/26 12:23:24 |
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Basic information
Public title
The study of the relationship between oxygen dose at night and arterial partial pressure of carbon dioxide in type 2 chronic respiratory failure patients
Acronym
The relationship between oxygen dose at night and arterial partial pressure of carbon dioxide
Scientific Title
The study of the relationship between oxygen dose at night and arterial partial pressure of carbon dioxide in type 2 chronic respiratory failure patients
Scientific Title:Acronym
The relationship between oxygen dose at night and arterial partial pressure of carbon dioxide
Region
| Japan |
Condition
Condition
Patients with chronic hypercapnic respiratory failure receiving a long-term oxygen therapy and noninvasive positive pressure ventilation (NPPV)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate what kind of influence various oxygen dose have on PtcCO2 and subjective symptoms
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between oxygen dose and some parameters (sleep structure, PtcCO2 at night, and SpO2 at night)
Key secondary outcomes
The relationship between oxygen dose and some parameters (respiratory status, sleepiness, sympathetic nerve activity, cardiovascular load, and pulmonary function)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Low dose oxygen, one night
(one week)
Middle dose oxygen, one night
(one week)
High dose oxygen, one night
Interventions/Control_2
Low dose oxygen, one night
(one week)
High dose oxygen, one night
(one week)
Middle dose oxygen, one night
Interventions/Control_3
Middle dose oxygen, one night
(one week)
Low dose oxygen, one night
(one week)
High dose oxygen, one night
Interventions/Control_4
Middle dose oxygen, one night
(one week)
High dose oxygen, one night
(one week)
Low dose oxygen, one night
Interventions/Control_5
High dose oxygen, one night
(one week)
Low dose oxygen, one night
(one week)
Middle dose oxygen, one night
Interventions/Control_6
High dose oxygen, one night
(one week)
Middle dose oxygen, one night
(one week)
Low dose oxygen, one night
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients receiving long-term oxygen therapy and long-term NPPV with chronic respiratory failure. Underling disease do not matter (COPD, Interstitial pneumoniae, Nontuberculous mycobacteriosis, Bronchiectasis, etc.)
Key exclusion criteria
Clinically unstable
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Sumi |
Organization
National Hospital Organization Minami-Kyoto Hospital
Division name
Department of Respiratory Medicine
Zip code
6100113
Address
Naka Ashihara 11, Joyo city, Kyoto, Japan
TEL
0774-52-0065
kensukesumi@gmail.com
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Sumi |
Organization
National Hospital Organization Minami-Kyoto Hospital
Division name
Department of Respiratory Medicine
Zip code
6100113
Address
Naka Ashihara 11, Joyo city, Kyoto, Japan
TEL
0774-52-0065
Homepage URL
kensukesumi@gmail.com
Sponsor or person
Institute
Department of Respiratory Medicine, National Hospital Organization Minami-Kyoto Hospital
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Respiratory Medicine, National Hospital Organization Minami-Kyoto Hospital
Address
Naka Ashihara 11, Joyo city, Kyoto, Japan
Tel
0774-52-0065
kensukesumi@gmail.com
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
| 2017 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_view_reg.cgi?recptno=R000033402
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
12
Results
There was no difference in mean nightly PtcCO2 between low, medium, and high oxygen flow rates; questionnaires on quality of life were also not significantly different for each.
Results date posted
| 2023 | Year | 03 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
12 patients with chronic respiratory failure on oxygen and NPPV
Participant flow
The patients slept at night with low, medium, and high flow oxygen, respectively, and various data were taken.
Adverse events
None
Outcome measures
The relationship between oxygen dose and some parameters (sleep structure, PtcCO2 at night, and SpO2 at night)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 20 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033402
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| Research case data specifications | |
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| Registered date | File name |
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