UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058574 |
|---|---|
| Receipt number | R000066859 |
| Scientific Title | Mechanical Energy and Ventilator-Induced Lung Injury: Insights from Four-Dimensional Dynamic CT |
| Date of disclosure of the study information | 2025/07/24 |
| Last modified on | 2025/07/24 04:29:12 |
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Basic information
Public title
Mechanical Energy and Ventilator-Induced Lung Injury: Insights from Four-Dimensional Dynamic CT
Acronym
Mechanical Energy and Ventilator-Induced Lung Injury: Insights from Four-Dimensional Dynamic CT
Scientific Title
Mechanical Energy and Ventilator-Induced Lung Injury: Insights from Four-Dimensional Dynamic CT
Scientific Title:Acronym
Mechanical Energy and Ventilator-Induced Lung Injury: Insights from Four-Dimensional Dynamic CT
Region
| Japan |
Condition
Condition
Patients who required mechanical ventilation.
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the relationship between mechanical energy measured at the bedside and tidal recruitment or strain in patients with acute respiratory failure, using four-dimensional dynamic respiratory CT (4D-CT), to deepen understanding of ventilator-induced lung injury (VILI) and develop safer ventilation strategies.
Basic objectives2
Others
Basic objectives -Others
To verify whether mechanical energy measured by the ventilator is associated with tidal recruitment and strain using 4D-CT, aiming to elucidate the pathophysiology of VILI and establish practical bedside assessment indicators.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate whether tidal lung hysteresis is associated with the proportion of tidal recruitment as assessed by four-dimensional dynamic CT (4D-CT)
Key secondary outcomes
To examine the association between dissipated energy and tidal recruitment
To examine the association between dissipated energy and strain
To evaluate the effect of dissipated energy on the spatial distribution of ventilator-induced lung injury (VILI)
To dynamically assess the impact of temporal changes in dissipated energy on regional lung mechanics
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients requiring mechanical ventilation in the intensive care unit
Hemodynamically stable under vasopressor support after initiation of mechanical ventilation
Physician judges that four-dimensional dynamic CT (4D-CT) is necessary and can be performed safely
Key exclusion criteria
Presence of pulmonary fistula or pneumothorax
Severe obstructive pulmonary disease
Pregnant women
Hemodynamic instability
Elevated intracranial pressure
Right heart failure
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | SEIYA |
| Middle name | |
| Last name | NISHIYAMA |
Organization
Jichi Medical University Saitama Medical Center
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
330-8503
Address
1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama, Japan
TEL
048-647-2111
s.nishiyama@jichi.ac.jp
Public contact
Name of contact person
| 1st name | SEIYA |
| Middle name | |
| Last name | NISHIYAMA |
Organization
Jichi Medical University Saitama Medical Center
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
330-8503
Address
1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama, Japan
TEL
048-647-2111
Homepage URL
s.nishiyama@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University Saitama Medical Center
Institute
Department
Personal name
SEIYA NISHIYAMA
Funding Source
Organization
internal fund
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
Department of Clinical Trial Promotion, Saitama Medical Center, Jichi Medical University
Address
1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama, Japan
Tel
048-647-2111
s-suishin@jichi.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 | 07 | Month | 24 | 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 | 06 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, four-dimensional dynamic chest CT (4D-CT) will be performed at the time when a chest CT is deemed necessary as part of standard clinical care. During transportation and scanning, patients will be managed under mechanical ventilation in the same manner as in routine practice. In addition, respiratory data will be collected before and after CT using electrical impedance tomography (EIT). All examinations and procedures, including 4D-CT, will be conducted within the scope of standard care and will not involve any additional invasiveness or special interventions. Notably, 4D-CT is already used in clinical practice, and its safety has been well established.
Management information
Registered date
| 2025 | Year | 07 | Month | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066859
