UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043423 |
|---|---|
| Receipt number | R000049575 |
| Scientific Title | Study with the transparent bandage on intravenous feeding fixation of children |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2024/03/01 09:44:06 |
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Basic information
Public title
Study with the transparent bandage on intravenous feeding fixation of children
Acronym
Study with the transparent bandage on intravenous feeding fixation of children
Scientific Title
Study with the transparent bandage on intravenous feeding fixation of children
Scientific Title:Acronym
Study with the transparent bandage on intravenous feeding fixation of children
Region
| Japan |
Condition
Condition
Extravasation
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Reduce the risk of delayed detection of extravascular leakage and the severity of symptoms.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Early detection of extravascular leakage
Key secondary outcomes
Complications such as allergies
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Fix the IV with a transparent bandage as in conventional splint fixation. In order to enable nurses and ICU physicians to prevent serious cases of extravascular leakage of IVs, it should be confirmed that the IV fixation area can be easily observed compared to conventional seine fixation. In addition, we will evaluate the method of fixation with transparent bandages in terms of safety, stress, and cleanliness.
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 | days-old | <= |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient in intensive care unit
Key exclusion criteria
with skin diseases, infections or wounds on the skin
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Kitano |
Organization
Osaka Medical and Pharmaceutical University
Division name
Intensive Care Unit
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki,Osaka, Japan
TEL
072-683-1221
manabu.kitano@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Kitano |
Organization
Osaka Medical and Pharmaceutical University
Division name
Intensive Care Unit
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki,Osaka, Japan
TEL
072-683-1221
Homepage URL
manabu.kitano@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical 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
Osaka Medical and Pharmaceutical University
Address
2-7 Daigaku-machi, Takatsuki,Osaka, Japan
Tel
072-683-1221
manabu.kitano@ompu.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
大阪医科薬科大学
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2021 | Year | 02 | Month | 24 | Day |
Last modified on
| 2024 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049575
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/09/25 | 【様式２】研究計画書0224.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
