UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059359 |
|---|---|
| Receipt number | R000067888 |
| Scientific Title | Novel Clinical Utility of Portable Dynamic Chest Radiography in the Intensive Care Unit (ICU) |
| Date of disclosure of the study information | 2025/10/09 |
| Last modified on | 2025/10/09 20:24:37 |
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Basic information
Public title
Novel Clinical Utility of Portable Dynamic Chest Radiography in the Intensive Care Unit (ICU)
Acronym
Novel Clinical Utility of DCR
Scientific Title
Novel Clinical Utility of Portable Dynamic Chest Radiography in the Intensive Care Unit (ICU)
Scientific Title:Acronym
Novel Clinical Utility of DCR
Region
| Japan |
Condition
Condition
Respiratory Failure
Classification by specialty
| Pneumology | Radiology | Emergency medicine |
| Intensive care medicine | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Portable dynamic chest radiography may enable a less invasive and more accurate functional assessment of the lung and diaphragm by capturing motion information that cannot be obtained through conventional static imaging. We will investigate the utility of this portable dynamic chest radiography in the ICU setting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Extubation success
Key secondary outcomes
ICU mortality
SBT success
30 days mortality
Difficult ventilator weaning
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients admitted to the ICU who required mechanical ventilation
Key exclusion criteria
(1)Patients with an ICD or a pacemaker
(2)Patients with IMPELLA support
(3)Patients who required reintubation during a single ICU admission
(4)Patients with pre-existing tracheostomy upon initiation of mechanical ventilation
(5) Patients with a pre-determined decision of 'No Reintubation' after extubation
(6)Pregnant patients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | Shime |
Organization
Hiroshima University
Division name
Department of Emergency and Critical Care Medicine
Zip code
734-8551
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
TEL
082-257-5555
nshime@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Rena |
| Middle name | |
| Last name | Akiyama |
Organization
Hiroshima University Hospital
Division name
Department of Diagnostic Radiology
Zip code
734-8551
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
TEL
082-257-5555
Homepage URL
r-akiyama@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Nobuaki Shime
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
Tel
082-257-5555
r-akiyama@hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
E2025-0068
Org. issuing International ID_1
Hiroshima University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will investigate the utility of portable dynamic chest radiography in the ICU setting.
Management information
Registered date
| 2025 | Year | 10 | Month | 09 | Day |
Last modified on
| 2025 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067888
