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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036082
Receipt No. R000041022
Scientific Title Safety of oxygen supplementation for infectious disease : an open-label , randomized , controlled pilot study
Date of disclosure of the study information 2019/03/05
Last modified on 2019/03/14

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Basic information
Public title Safety of oxygen supplementation for infectious disease : an open-label , randomized , controlled pilot study
Acronym Safety of oxygen supplementation for infectious disease : an open-label , randomized , controlled pilot study
Scientific Title Safety of oxygen supplementation for infectious disease : an open-label , randomized , controlled pilot study
Scientific Title:Acronym Safety of oxygen supplementation for infectious disease : an open-label , randomized , controlled pilot study
Region
Japan

Condition
Condition Infection diseases
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of oxygen supplementation (SpO2>=95%) for patients with oxygen desaturation due to infection diseases.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes hospital discharge outcomes
(mortality,transfer to acute care hospitals,transfer to chronic care hospitals or nursing homes)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Oxygen therapy to maintain SpO2 >=95%
Interventions/Control_2 Follow-up(SpO2 >=90%)
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 1)20 years and older
2)Signed informed consent
3)Do not home oxygen therapy user
Key exclusion criteria 1)Not signed informed consent
2)Severe concomitant disease (Dialysis,cancer-carrying patient)
3)Pregnancy, breastfeeding
4)Home oxygen therapy user
5)Chronic type2 respiratory failure
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Toshikazu
Middle name
Last name Abe
Organization Juntendo University Hospital
Division name Department of General Medicine
Zip code 113-8421
Address 3-1-3,Hongo,Bunkyo-ku,Tokyo
TEL 03-3813-3111
Email to-abe@juntendo.ac.jp

Public contact
Name of contact person
1st name Toshikazu
Middle name
Last name Abe
Organization Juntendo University Hospital
Division name Department of General Medicine
Zip code 113-8421
Address 3-1-3,Hongo,Bunkyo-ku,Tokyo
TEL 03-3813-3111
Homepage URL
Email to-abe@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Juntendo University
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 Hospital Ethics Committee Juntendo University Hospital
Address 3-1-3,Hongo,Bunkyo-ku,Tokyo
Tel 03-3813-3111
Email kenkyu5858@juntendo.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
2019 Year 03 Month 05 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
2019 Year 02 Month 19 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 05 Day
Last modified on
2019 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041022

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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