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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029222
Receipt No. 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 2019/06/18

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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
Email 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
Email kensukesumi@gmail.com

Sponsor
Institute Department of Respiratory Medicine, National Hospital Organization Minami-Kyoto Hospital
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 Department of Respiratory Medicine, National Hospital Organization Minami-Kyoto Hospital
Address Naka Ashihara 11, Joyo city, Kyoto, Japan
Tel 0774-52-0065
Email 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
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
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
2020 Year 09 Month 30 Day
Date of closure to data entry
2020 Year 09 Month 30 Day
Date trial data considered complete
2020 Year 09 Month 30 Day
Date analysis concluded
2020 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 20 Day
Last modified on
2019 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033402

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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