UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059177 |
|---|---|
| Receipt number | R000067684 |
| Scientific Title | Exploratory study on lung perfusion measurement using electrical impedance tomography |
| Date of disclosure of the study information | 2025/09/25 |
| Last modified on | 2025/09/24 16:42:43 |
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Basic information
Public title
Exploratory study on lung perfusion measurement using electrical impedance tomography
Acronym
Exploratory study on lung perfusion measurement using electrical impedance tomography
Scientific Title
Exploratory study on lung perfusion measurement using electrical impedance tomography
Scientific Title:Acronym
Exploratory study on lung perfusion measurement using electrical impedance tomography
Region
| Japan |
Condition
Condition
acute respiratory failure with PaO2/FIO2 less than 300 mmHg and mechanically ventilated
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
When monitoring pulmonary blood flow using electrical impedance tomography (EIT), ventilation is typically paused to avoid measurement interference from ventilation. However, the extent to which measurement results are affected when measurements are taken without pausing ventilation has not been investigated. This study investigates the difference in pulmonary blood flow measurements between these two methods in the same hypoxemic mechanically ventilated patients, exploring the necessity of ventilation cessation during measurement.
Basic objectives2
Others
Basic objectives -Others
Characteristics in regional pulmonary blood flow distribution due to underlying diseases
Correlation between dead space ventilation ratio, oxygenation capacity obtained from respiratory data, and ventilation-perfusion ratio
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Consistency of distribution of pulmonary blood flow using different methods (measurements with or without ventilation)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention to measure pulmonary blood flow without discontinuing mechanical ventilation
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
1) The patient exhibits hypoxemia (PaO2/FIO2 below 300 mmHg) and is receiving mechanical ventilation.
2) A central venous line is inserted via the internal jugular vein.
3) The patient is 18 years of age or older at the time of enrollment.
4) Written informed consent for study participation has been obtained from the patient or a legally authorized representative.
Key exclusion criteria
1) Hypotension or heart failure requiring high-dose catecholamine administration.
2) Renal failure requiring dialysis.
3) Hypernatremia (latest sodium value within 1 day prior to registration more than 145 mEq/L).
4) Thoracic deformity observed on chest CT or chest X-ray.
5) Pacemaker implantation.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | ATSUKO |
| Middle name | |
| Last name | SHONO |
Organization
Shimane university hospital
Division name
Intensive Care Medicine
Zip code
693-8501
Address
Enya 89-1, Izumo city, Shimane, Japan
TEL
0853-20-2295
atsukos@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Matsumoto |
Organization
Shimane university hospital
Division name
Intensive Care Medicine
Zip code
693-8501
Address
Enya 89-1, Izumo city, Shimane, Japan
TEL
0853-20-2295
Homepage URL
keita.ma@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane university
Institute
Department
Personal name
Funding Source
Organization
Shimane university hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
Enya 89-1, Izumo city, Shimane, Japan
Tel
0853-20-2515
kenkyu@med.shimane-u.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 | 09 | Month | 25 | 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
| 2025 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | 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
Management information
Registered date
| 2025 | Year | 09 | Month | 24 | Day |
Last modified on
| 2025 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067684
