UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031052
Receipt number R000035453
Scientific Title A prospective randomized control study for chest radiographs
Date of disclosure of the study information 2020/05/01
Last modified on 2020/08/04 10:33:04

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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 or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



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

Value
https://center6.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