UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057955 |
|---|---|
| Receipt number | R000066257 |
| Scientific Title | Study on microaspiration around tracheal tube cuffs using tracheal models created with a 3D printer |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/05/23 22:06:05 |
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Basic information
Public title
Study on microaspiration around tracheal tube cuffs using tracheal models created with a 3D printer
Acronym
Study on microaspiration around tracheal tube cuffs using tracheal models created with a 3D printer
Scientific Title
Study on microaspiration around tracheal tube cuffs using tracheal models created with a 3D printer
Scientific Title:Acronym
Study on microaspiration around tracheal tube cuffs using tracheal models created with a 3D printer
Region
| Japan |
Condition
Condition
tracheal intubation
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Consideration of the material and size of tracheal tubes to minimize microaspiration around the cuff
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of fluid leaked from around the cuff
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have already undergone chest CT imaging for other purposes
Key exclusion criteria
no
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | shinji |
| Middle name | |
| Last name | takahashi |
Organization
Juntendo University Hospital, Urayasu
Division name
anesthesiology
Zip code
279-0021
Address
2-1-1 Tomioka, Urayasu-shi, Chiba
TEL
047-353-3111
hiramot@gmail.com
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Hiramoto |
Organization
Juntendo University Hospital, Urayasu
Division name
anesthesiology
Zip code
279-0021
Address
2-1-1 Tomioka, Urayasu-shi, Chiba
TEL
047-353-3111
Homepage URL
hiramot@gmail.com
Sponsor or person
Institute
juntendo university
Institute
Department
Personal name
Funding Source
Organization
no
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
Juntendo University School of Medicine Affiliated Juntendo Hospital Clinical Research and Clinical Trials Center Office of the Ethics Committee for Medical Research
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
Tel
03-5802-1584
hiramot@gmail.com
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 | 06 | 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 | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Creating an experimental tracheal model from chest CT data obtained in routine clinical practice
Management information
Registered date
| 2025 | Year | 05 | Month | 23 | Day |
Last modified on
| 2025 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066257
