UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043556 |
|---|---|
| Receipt number | R000049744 |
| Scientific Title | Investigation of the tip position of pediatric tracheal tube (Microcuff tube) |
| Date of disclosure of the study information | 2021/03/09 |
| Last modified on | 2021/03/09 11:20:55 |
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Basic information
Public title
Investigation of the tip position of pediatric tracheal tube (Microcuff tube)
Acronym
Study about Mincrocuff tube
Scientific Title
Investigation of the tip position of pediatric tracheal tube (Microcuff tube)
Scientific Title:Acronym
Study about Mincrocuff tube
Region
| Japan |
Condition
Condition
pediatric patients from 1-3 years old who receive surgeries by pediatric surgeons.
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to improve management of Microcuff tubes during operation and postoperative period by investigating their tip positions.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the relation between the tip of Microcuff tube and the tracheal wall
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
| 1 | years-old | <= |
Age-upper limit
| 5 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA1
General anesthesia with tracheal intubation
the size of the tracheal tube from3.5mm-4.5mm
Key exclusion criteria
the size of the tracheal tube smaller than 3mm or larger than5mm
ASA-PS more than2
not general anesthesia with tracheal intubation
others
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kataoka |
| Middle name | |
| Last name | Kumi |
Organization
Juntendo University Hospital
Division name
Anesthesiology
Zip code
1138431
Address
3-1-3 Hongo Bunkyo-ku Tokyo
TEL
0338133111
kkataoka@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kataoka |
| Middle name | |
| Last name | Kumi |
Organization
Juntendo University Hospital
Division name
Anesthesiology
Zip code
1138431
Address
3-1-3 Hongo Bunkyo-ku Tokyo
TEL
0338133111
Homepage URL
kkataoka@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
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
Anesthesiology
Address
3-1-3 Hongo Bunkyo-ku Tokyo
Tel
0338133111
kkataoka@juntendo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
20-272
Org. issuing International ID_1
Juntendo University Hospital Ethical Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 09 | 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
| 2021 | Year | 03 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation
Management information
Registered date
| 2021 | Year | 03 | Month | 09 | Day |
Last modified on
| 2021 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049744
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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