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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024678
Receipt No. R000028395
Scientific Title Deveopment of respiratory sound analysis system as a remote medical support tool in bacterial pneumonia
Date of disclosure of the study information 2016/11/03
Last modified on 2018/11/05

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Basic information
Public title Deveopment of respiratory sound analysis system as a remote medical support tool in bacterial pneumonia
Acronym Respiratory sound analysis in pneumonia
Scientific Title Deveopment of respiratory sound analysis system as a remote medical support tool in bacterial pneumonia
Scientific Title:Acronym Respiratory sound analysis in pneumonia
Region
Japan

Condition
Condition pneumonia
Classification by specialty
Medicine in general Pneumology Infectious disease
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the utility of respiratory sound analysis in the diagnosis of pneumonia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Decision threshold of respiratory sound analysis in the diagnosis of pneumonia
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 1) informed consent
2) clinical diagnosis of bacterial pneumonia
3) subjects who will be treated with antibiotics
Key exclusion criteria 1) subjects who need to receive emergency care
2)Subjects who are difficult to hold the rest
3) Subjects who are difficult to auscultation
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuto Matsunaga
Organization Graduate School of Medicine, Yamaguchi University
Division name Department of Respiratory Medicine and Infectious Disease
Zip code
Address 1-1-1 Minami-kogushi, Ube, Yamaguchi
TEL 0836-85-3123
Email kokyuki@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuto Matsunaga
Organization Graduate School of Medicine, Yamaguchi University
Division name Department of Respiratory Medicine and Infectious Disease
Zip code
Address 1-1-1 Minami-kogushi, Ube, Yamaguchi
TEL 0836-85-3123
Homepage URL
Email kokyuki@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University
Institute
Department

Funding Source
Organization Yamaguchi industrial strategy section
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor Graduate school of sciences and technology for innovation
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 03 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 09 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 12 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 This study will observe the changes in respiratory sound before and after pneumonia treatment in the same patient.

Management information
Registered date
2016 Year 11 Month 02 Day
Last modified on
2018 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028395

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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