UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024777 |
|---|---|
| Receipt number | R000028504 |
| Scientific Title | Fitting chcaracteristics of N95 filtering-facepiece respirators used Osaka medical college hospital for prevention of airborne infection |
| Date of disclosure of the study information | 2016/11/15 |
| Last modified on | 2017/05/15 17:18:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Fitting chcaracteristics of N95 filtering-facepiece respirators used Osaka medical college hospital for prevention of airborne infection
Acronym
Fitting characteristics of N95 filtering-facepiece respirator
Scientific Title
Fitting chcaracteristics of N95 filtering-facepiece respirators used Osaka medical college hospital for prevention of airborne infection
Scientific Title:Acronym
Fitting characteristics of N95 filtering-facepiece respirator
Region
| Japan |
Condition
Condition
Prevention of airborne infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To provide a mask constituted so as to effectively prevent airborne infection, fit factors and inward leakage of some N95 filtering-facepiece respirators were measured by mechanical fit-tester.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Fitting ratio of N95 filtering-facepiece respirator
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hospital care workers and students of Osaka medical college hospital
Key exclusion criteria
Disagreement for this study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Ukimura |
Organization
Osaka medical college hospital
Division name
Infection control center
Zip code
Address
2-7 Daigakumachi Takatsuki-city, Osaka, Japan
TEL
072-683-1221
in3011@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Ukimura |
Organization
Osaka medical college hospital
Division name
Infection control center
Zip code
Address
2-7 Daigakumachi Takatsuki-city, Osaka, Japan
TEL
072-683-1221
Homepage URL
in3011@osaka-med.ac.jp
Sponsor or person
Institute
Osaka medical college
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2016 | Year | 11 | 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
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To provide a mask constituted so as to effectively prevent airborne infection, fit factors and inward leakage of some N95 filtering-facepiece respirators were measured by mechanical fit-tester. We analyze type of N95 filtering-facepiece respirators, age, sex, BMI and the shape of face.
Management information
Registered date
| 2016 | Year | 11 | Month | 09 | Day |
Last modified on
| 2017 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028504
