UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035010
Receipt number R000039919
Scientific Title Study on pulmonary function imaging diagnosis by chest X-ray dynamics photographing with motion picture compatible flat panel detector.Application 2 in emergency area: For chest trauma patients.
Date of disclosure of the study information 2018/12/01
Last modified on 2022/02/11 13:10:36

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Basic information

Public title

Study on pulmonary function imaging diagnosis by chest X-ray dynamics photographing with motion picture compatible flat panel detector.Application 2 in emergency area: For chest trauma patients.

Acronym

Clinical application of chest x-ray dynamic photography 2

Scientific Title

Study on pulmonary function imaging diagnosis by chest X-ray dynamics photographing with motion picture compatible flat panel detector.Application 2 in emergency area: For chest trauma patients.

Scientific Title:Acronym

Clinical application of chest x-ray dynamic photography 2

Region

Japan


Condition

Condition

Chest trauma patients

Classification by specialty

Emergency medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Observe the effect on respiratory function in chest trauma patients using chest x-ray dynamic imaging

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sensitivity for diagnosis of pulmonary contusion in measurement method of respiratory variation of permeability of 18 lung fields by chest X-ray dynamic imaging apparatus with contrast CT examination as a reference

Key secondary outcomes

1. Specificity for diagnosis of pulmonary contusion in measurement method of respiratory variation of permeability of 18 lung fields by chest X-ray dynamic imaging apparatus with contrast CT examination as a reference.
2. Chronological comparison of throat movable range (difference of thoracic area between inspiratory and expiratory) and variation of pixel value in inspiratory and expiratory phase with respiratory function test (%VC, FEV1.0) as references


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

Patients who are hospitalized at the University Hospital or scheduled to be hospitalized and satisfy the following conditions
1) Be an adult over 20 years old
2) Written informed consent
3) Patients suspected of chest trauma or patients diagnosed with chest trauma
4) Chest CT contrast test scheduled for diagnosis or follow-up of chest trauma

Key exclusion criteria

1) have allergy to the contrast agent
2) During pregnancy, possibility of pregnancy, delivery within 28 days, breast-feeding
3) Psychiatric disorder or psychiatric symptoms are merged and it is judged difficult to participate in the trial
4) Severe cases (during artificial respiration, SpO2 <93% even when administered oxygen, wearing an extracorporeal circulation assisting device, shock index> 1, during noradrenaline administration, GCS <13)
5) Even if it does not apply to 4) above, the patient who judged treatment as priority by the attending physician

Target sample size

50


Research contact person

Name of lead principal investigator

1st name JIRO
Middle name
Last name SHIMADA

Organization

Fukushima Medical University

Division name

Futaba Emergency General Medical Support Center

Zip code

9601247

Address

1 Hikariga-oka, Fukushima City, JAPAN

TEL

0245471111

Email

jshimada@fmu.ac.jp


Public contact

Name of contact person

1st name JIRO
Middle name
Last name SHIMADA

Organization

Fukushima Medical University hospital

Division name

Emergency and Critical Care Center

Zip code

9601247

Address

1 Hikariga-oka, Fukushima City, JAPAN

TEL

0245471111

Homepage URL


Email

jshimada3@gmail.com


Sponsor or person

Institute

Fukushima Medical University hospital

Institute

Department

Personal name



Funding Source

Organization

Konica Minolta Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fukushima Medical University Certified Review Board

Address

1 Hikariga-oka, Fukushima City, JAPAN

Tel

0245471111

Email

fmucrb@fmu.ac.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



Other administrative information

Date of disclosure of the study information

2018 Year 12 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


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

Terminated

Date of protocol fixation

2017 Year 10 Month 01 Day

Date of IRB

2018 Year 12 Month 18 Day

Anticipated trial start date

2017 Year 12 Month 01 Day

Last follow-up date

2021 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Case registration is delayed
Some tests cannot be performed due to the effects of coronavirus infection
Due to the coronavirus pandemic, case registration did not proceed and was canceled.


Management information

Registered date

2018 Year 11 Month 26 Day

Last modified on

2022 Year 02 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039919


Research Plan
Registered date File name
2019/02/21 4研究計画書-臨床研究審査委員会コニカ胸部外傷.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name