UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058817 |
|---|---|
| Receipt number | R000067080 |
| Scientific Title | Early diagnosis of ARDS (acute respiratory distress syndrome) using dynamic X-ray imaging system |
| Date of disclosure of the study information | 2025/08/31 |
| Last modified on | 2025/08/17 11:58:37 |
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Basic information
Public title
Early diagnosis of ARDS (acute respiratory distress syndrome) using dynamic X-ray imaging system
Acronym
Early ARDS Detection with Dynamic X-ray Imaging
Scientific Title
Early diagnosis of ARDS (acute respiratory distress syndrome) using dynamic X-ray imaging system
Scientific Title:Acronym
Early ARDS Detection with Dynamic X-ray Imaging
Region
| Japan |
Condition
Condition
ARDS (acute respiratory distress syndrome)
Classification by specialty
| Pneumology | Radiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The question is whether ARDS can be diagnosed before it becomes severe, in the early exudative or proliferative stages, with a new imaging technique (a portable device that can be performed in hospital rooms) that can replace conventional chest radiographs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Ventilation and blood flow distribution images obtained from dynamic x-ray imaging images, lung and diaphragm motion change volume and rate of change
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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with acute respiratory failure (ARDS and non-ARDS patients) treated in the intensive care unit (ICU) of Shiga University Hospital from December 1, 2024 to March 31, 2028 AD
Key exclusion criteria
Patients under 18 years of age
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | AKINAGA |
| Middle name | |
| Last name | SONODA |
Organization
Shiga University of Medical Science
Division name
Department of Radiology
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
0775482288
akinaga@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | AKINAGA |
| Middle name | |
| Last name | SONODA |
Organization
Shiga University of Medical Science
Division name
Department of Radiology
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
0775482288
Homepage URL
akinaga@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
AKINAGA SONODA
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
Tel
077-548-3576
hqrec@belle.shiga-med.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
| 2025 | Year | 08 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing special to mention
Management information
Registered date
| 2025 | Year | 08 | Month | 17 | Day |
Last modified on
| 2025 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067080
