UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060058 |
|---|---|
| Receipt number | R000068679 |
| Scientific Title | Effects of Negative-Pressure Ventilation on Pulmonary Ventilation and Its Evaluation Using Electrical Impedance Tomography |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/12/11 18:52:56 |
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Basic information
Public title
Effects of Negative-Pressure Ventilation on Pulmonary Ventilation and Its Evaluation Using Electrical Impedance Tomography
Acronym
Effects of Negative-Pressure Ventilation on Pulmonary Ventilation and Its Evaluation Using Electrical Impedance Tomography
Scientific Title
Effects of Negative-Pressure Ventilation on Pulmonary Ventilation and Its Evaluation Using Electrical Impedance Tomography
Scientific Title:Acronym
Effects of Negative-Pressure Ventilation on Pulmonary Ventilation and Its Evaluation Using Electrical Impedance Tomography
Region
| Japan |
Condition
Condition
Patients with mechanical ventilation
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate, using electrical impedance tomography (EIT), the effects of negative-pressure ventilation on the distribution of ventilation and functional residual capacity in adults requiring mechanical ventilation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
delta-EELI
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Negative pressure 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
Age 18 years or older
Undergoing surgery under general anesthesia
Patients who are admitted to the intensive care unit postoperatively while intubated and are expected to remain on mechanical ventilation until the following morning
Key exclusion criteria
Patients who meet the study criteria and are participating in this study for the second time or more during the study period
Patients scheduled to undergo thoracic surgery or any surgical incision involving the chest
Patients deemed unsuitable for participation in this study by the principal investigator or co-investigators for any other reason
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kimura |
Organization
Kyoto University Hospital
Division name
Department of Anesthesiology
Zip code
606-8507
Address
54 Shogoin Kawaracho, Sakyo Ward, Kyoto, 606-8507
TEL
0570-030-311
ctsodan@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kimura |
Organization
Kyoto University Hospital
Division name
Department of Anesthesiology
Zip code
606-8507
Address
54 Shogoin Kawaracho, Sakyo Ward, Kyoto, 606-8507
TEL
0570-030-311
Homepage URL
ctsodan@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IMI
IRB Contact (For public release)
Organization
Kyoto University Hospital
Address
54 Shogoin Kawaracho, Sakyo Ward, Kyoto, 606-8507
Tel
0570-030-311
ctsodan@kuhp.kyoto-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
| 2026 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2029 | 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 | 12 | Month | 11 | Day |
Last modified on
| 2025 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068679
