UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024777
Receipt No. 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

* 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
Email 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
Email in3011@osaka-med.ac.jp

Sponsor
Institute Osaka medical college
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028504

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.