UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048650 |
|---|---|
| Receipt number | R000055437 |
| Scientific Title | A study on the efficiency of oxygen administration by different face masks to subjects wearing surgical masks |
| Date of disclosure of the study information | 2022/08/15 |
| Last modified on | 2023/06/06 10:11:20 |
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Basic information
Public title
A study on the efficiency of oxygen administration by different face masks to subjects wearing surgical masks
Acronym
A study on oxygen administration efficiency
Scientific Title
A study on the efficiency of oxygen administration by different face masks to subjects wearing surgical masks
Scientific Title:Acronym
A study on oxygen administration efficiency
Region
| Japan |
Condition
Condition
not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine if there is a difference in the efficiency of oxygen administration under the combined use of a surgical mask and a face mask in healthy volunteers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oxigen Reserve Index(ORI)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The relationship between surgical masks and face masks
Interventions/Control_2
Types of face masks
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy volunteers between the ages of 20 and 60
2) Persons with legal capacity to consent
Key exclusion criteria
1) People with a history of respiratory disease
2) People with a history of smoking
3) People who may be infected with a new type of coronavirus
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Takazawa |
Organization
Gunma University Hospital
Division name
Intensive Care Unit
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-7720
gun-tokue@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Kamiyama |
Organization
Gunma University Hospital
Division name
Intensive Care Unit
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8698
Homepage URL
gun-tokue@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Committee, Gunma University Hospital
Address
3-39-15 Showa-machi, Maebashi, Gunma, Japan
Tel
027-220-7111
ciru_hitotaisho-irb@ml.gunma-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
| 2022 | Year | 08 | Month | 15 | 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
24
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
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2022 | 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
| 2022 | Year | 08 | Month | 12 | Day |
Last modified on
| 2023 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055437
