UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059657 |
|---|---|
| Receipt number | R000068215 |
| Scientific Title | The effect of expiratory time on lung ventilation in mechanically ventilated pediatric patients using electrical impedance tomography |
| Date of disclosure of the study information | 2025/11/07 |
| Last modified on | 2025/11/06 08:32:50 |
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Basic information
Public title
The effect of expiratory time on lung ventilation in mechanically ventilated pediatric patients using electrical impedance tomography
Acronym
The effect of expiratory time on lung ventilation in mechanically ventilated pediatric patients using electrical impedance tomography
Scientific Title
The effect of expiratory time on lung ventilation in mechanically ventilated pediatric patients using electrical impedance tomography
Scientific Title:Acronym
The effect of expiratory time on lung ventilation in mechanically ventilated pediatric patients using electrical impedance tomography
Region
| Japan |
Condition
Condition
Surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates the effects of changes in expiratory time on lung overdistension and atelectasis in children undergoing general anesthesia using electrical impedance tomography (EIT).
Basic objectives2
Others
Basic objectives -Others
Understanding the effect of expiratory time on pulmonary ventilation would provide substantial benefits for respiratory management of pediatric patients requiring mechanical ventilation in operating rooms and intensive care units.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
C loss (%) in EIT: Represents the regional loss of compliance compared with the reference condition.
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
| 6 | months-old | <= |
Age-upper limit
| 24 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Age between 6 and 24 months
Undergoing surgery under general anesthesia with endotracheal intubation
Written informed consent obtained from the patient's parent or legal guardian for participation in the study
Key exclusion criteria
Patients participating in this study for the second time or more during the study period
Patients with cardiovascular disease, pacemakers, or respiratory disease
Patients undergoing neurosurgery, cardiac surgery, or transplant surgery
Patients scheduled for thoracic or abdominal surgery
Patients with a respiratory infection within the past month
Patients scheduled to use a cuffless endotracheal tube
Patients undergoing surgery in the prone position
Patients deemed unsuitable for participation in this study by the principal investigator or co-investigators
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
Anesthesiology
Zip code
606-8507
Address
54 Shogoin Kawaracho, Sakyo Ward, Kyoto
TEL
0570-030-311
kimsato1034@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kimura |
Organization
Kyoto University Hospital
Division name
Anesthesiology
Zip code
606-8507
Address
54 Shogoin Kawaracho, Sakyo Ward, Kyoto
TEL
0570-030-311
Homepage URL
kimsato1034@hotmail.co.jp
Sponsor or person
Institute
Kyoto University
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)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507
Tel
075-366-7618
ethcom@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
| 2025 | Year | 11 | Month | 07 | 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 | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | 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
NA
Management information
Registered date
| 2025 | Year | 11 | Month | 06 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068215
