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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043867
Receipt No. 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 2021/04/08

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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
Email 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
Email sjinkun@hp-cqm.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2021 Year 05 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
2021 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.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


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