UMIN-CTR Clinical Trial

Basic information
Public title	A prospective randomized control study for chest radiographs
Acronym	A randomized control study for chest radiographs
Scientific Title	A prospective randomized control study for chest radiographs
Scientific Title:Acronym	A randomized control study for chest radiographs
Region	Japan

Condition
Condition	none
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine how to take an effective chest X- ray
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	accuracy of chest X-p each time
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	To use a device at the timing of chest X-p
Interventions/Control_2	Not to use a device at the timing of chest X-p(control)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who needed to take chest X-p at outpatient department
Key exclusion criteria	(1)patients who aspirate a foreign body (2)patients who need for emergency treatment (3)patients who has diseases of bone, diaphragm, lateral curvature or thoracic deformity
Target sample size	124

Research contact person
Name of lead principal investigator	1st name Yasuo Middle name Last name SUGIURA
Organization	National Center for Global Health and Medicine
Division name	Bureau of International Health Cooperation
Zip code	162-8655
Address	1-21-1 Toyama, Shinjyuku-ku, Tokyo
TEL	03-3202-7181
Email	yasugiura@it.ncgm.go.jp

Public contact
Name of contact person	1st name Yasuo Middle name Last name SUGIURA
Organization	National Center for Global Health and Medicine
Division name	Bureau of International Health Cooperation
Zip code	162-8655
Address	1-21-1 Toyama, Shinjyuku-ku, Tokyo
TEL	03-3202-7181
Homepage URL
Email	yasugiura@it.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center for Global Health and Medicine
Address	1-2-1 Toyama, Shinjyuku-ku Tokyo Japan
Tel	03-3202-7181
Email	yasugiura@it.ncgm.go.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	国立国際医療研究センター病院（東京都）

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 01 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	124
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	Main results already published
Date of protocol fixation	2017 Year 08 Month 28 Day
Date of IRB	2018 Year 02 Month 09 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2019 Year 10 Month 08 Day
Date of closure to data entry	2019 Year 12 Month 28 Day
Date trial data considered complete	2020 Year 01 Month 31 Day
Date analysis concluded	2020 Year 03 Month 20 Day

Other
Other related information	The result of this research was published in the journal as follows; Biosci Trends . 2020 Jul 17;14(3):200-205. doi: 10.5582/bst.2020.03024. Epub 2020 May 17. A breathing movement sensor for chest radiography during inspiration in children aged less than 3 years: a prospective randomized controlled study

Management information
Registered date	2018 Year 01 Month 29 Day
Last modified on	2020 Year 08 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035453

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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