UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052226 |
|---|---|
| Receipt number | R000059611 |
| Scientific Title | Examination of inhaled oxygen concentration under masked conditions |
| Date of disclosure of the study information | 2023/09/16 |
| Last modified on | 2024/06/20 23:04:45 |
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Basic information
Public title
Examination of inhaled oxygen concentration under masked conditions
Acronym
Examination of inhaled oxygen concentration under masked conditions
Scientific Title
Examination of inhaled oxygen concentration under masked conditions
Scientific Title:Acronym
Examination of inhaled oxygen concentration under masked conditions
Region
| Japan |
Condition
Condition
Healthy adults who are at least 18 years of age and have given consent
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the concentration of inhaled oxygen when administering oxygen with and without a surgical mask
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Examination of the difference in inhaled oxygen concentration with and without surgical mask.
Key secondary outcomes
Examination of differences in inhaled carbon dioxide concentrations with and without surgical masks.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults who are at least 18 years of age and have given consent
Key exclusion criteria
with blood coagulation disorders
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kauhiro |
| Middle name | |
| Last name | Shirozu |
Organization
Kyushu University Hospital
Division name
Operating rooms
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, JAPAN
TEL
092-642-5714
shirozu.kazuhiro.334@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Shirozu |
Organization
Kyushu University Hospital
Division name
Operating rooms
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, JAPAN
TEL
092-642-5714
Homepage URL
shirozu.kazuhiro.334@m.kyushu-u.ac.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Kazuhiro Shirozu
Funding Source
Organization
self
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
KYUSHU UNIVERSITY Center for Clinical and Translational Research
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, JAPAN
Tel
092-642-5082
byskenkyu@jimu.kyushu-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
福岡県
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 16 | 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
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Inhaled oxygen and carbon dioxide concentrations (FIO2/FICO2) and exhaled terminal oxygen and carbon dioxide concentrations (ETO2/ETCO2) were measured when oxygen was administered in the range 0-6 L/min using an open face mask (Atom Medical Corporation) with and without a surgical mask (Osaki Medical Corporation). Measurements were taken using a multi-gas module (Nihon Kohden Co., Ltd.) with a gas sampling tube inserted up to the nasal cavity and recorded at 3-second intervals for 2 minutes for comparison.
Management information
Registered date
| 2023 | Year | 09 | Month | 16 | Day |
Last modified on
| 2024 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059611
