UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036082 |
|---|---|
| Receipt number | 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 10:17:26 |
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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
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
to-abe@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041022
