UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042557 |
|---|---|
| Receipt number | R000048575 |
| Scientific Title | The Impact of Surgical Masks on Oxygen Therapy with Oxygen Masks |
| Date of disclosure of the study information | 2020/11/26 |
| Last modified on | 2022/06/20 23:47:57 |
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Basic information
Public title
The Impact of Surgical Masks on Oxygen Therapy with Oxygen Masks
Acronym
The Impact of Surgical Masks on Oxygen Therapy with Oxygen Masks
Scientific Title
The Impact of Surgical Masks on Oxygen Therapy with Oxygen Masks
Scientific Title:Acronym
The Impact of Surgical Masks on Oxygen Therapy with Oxygen Masks
Region
| Japan |
Condition
Condition
Adult Healthy Volunteers
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine whether a surgical mask under an oxygen mask will affect oxygen therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The fraction of inspired oxygen (FiO2) , The partial pressure of inspired carbon dioxide
Key secondary outcomes
The fraction of exhaled oxygen, The partial pressure of exhaled carbon dioxide, Percutaneous arterial oxygen saturation(SpO2)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Wearing an oxygen mask with a surgical mask
Interventions/Control_2
Wearing an oxygen mask without a surgical mask
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
Male and female adult volunteers aged 20 years or older with ASA(American Society of Anesthesia) PS(Physical Status) 1-2 with no underlying respiratory diseases and Hugh-Jones classification grade I
Key exclusion criteria
ASA PS3 or higher
Underlying respiratory disease and a Hugh-Jones classification of grade II or higher
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | Kinoshita |
Organization
Tokushima University Hospital
Division name
Anesthesiology
Zip code
770-8503
Address
2-50-1, Kuramoto-cho, Tokushima, Tokushima, Japan
TEL
088-633-7181
michiko-kinoshita@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Kinoshita |
Organization
Tokushima University Hospital
Division name
Anesthesiology
Zip code
770-8503
Address
2-50-1, Kuramoto-cho, Tokushima, Tokushima, Japan
TEL
088-633-7181
Homepage URL
michiko-kinoshita@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital, Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Tokushima University Hospital, Anesthesiology
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
The Ethics Committee of Tokushima University Hospital
Address
2-50-1, Kuramoto-cho, Tokushima, Tokushima, Japan
Tel
088-633-7181
michiko-kinoshita@tokushima-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
| 2020 | Year | 11 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
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
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2020 | Year | 11 | Month | 26 | Day |
Last modified on
| 2022 | 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=R000048575
