UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043867 |
|---|---|
| Receipt number | R000050077 |
| Scientific Title | A Study on the Concentration of Inhaled Oxygen when Oxygen is Administered with an Oxygen Mask while Using a Surgical Mask:A study on the appropriate oxygen administration method under Covid 19 epidemic conditions. |
| Date of disclosure of the study information | 2021/04/08 |
| Last modified on | 2022/08/12 16:14:33 |
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Basic information
Public title
A Study on the Concentration of Inhaled Oxygen when Oxygen is Administered with an Oxygen Mask while Using a Surgical Mask:A study on the appropriate oxygen administration method under Covid 19 epidemic conditions.
Acronym
A study on the appropriate oxygen administration method under Covid 19 epidemic conditions.
Scientific Title
A Study on the Concentration of Inhaled Oxygen when Oxygen is Administered with an Oxygen Mask while Using a Surgical Mask:A study on the appropriate oxygen administration method under Covid 19 epidemic conditions.
Scientific Title:Acronym
A study on the appropriate oxygen administration method under Covid 19 epidemic conditions.
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
When oxygen is administered to a subject wearing a surgical mask over it, clarify whether the inhaled oxygen concentration at the mouth reaches the desired concentration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inhalation oxygen concentration in the mouth, pharynx, and nasal cavity during normal oxygen administration and when using a surgical mask
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oxygen administration
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteer
The participants themselves have received sufficient explanation of the research content and have given written consent.
Key exclusion criteria
If the participant has a disease for which oxygen administration is considered harmful, such as interstitial pneumonia.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Sato |
Organization
Osaka University Hospital
Division name
Department of Clinical Quality Management
Zip code
565-0871
Address
Yamadaoka 2-15, Suita, Osaka, Japan
TEL
06-6879-5955
sjinkun@hp-cqm.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Sato |
Organization
Osaka University Hospital
Division name
Department of Clinical Quality Management
Zip code
565-0871
Address
Yamadaoka 2-15, Suita, Osaka, Japan
TEL
06-6879-5955
Homepage URL
sjinkun@hp-cqm.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yokohama City University Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Hospital
Address
Yamadaoka 2-15, Suita, Osaka, Japan
Tel
06-6879-5955
rinri@hp-cqm.med.osaka-u.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
| 2021 | Year | 04 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 08 | Day |
Last modified on
| 2022 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050077
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
