UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036169 |
|---|---|
| Receipt number | R000041208 |
| Scientific Title | Comparison of short-axis out-of-plane and long-axis in-plane ultrasound-guided central venous catheterization in pediatric |
| Date of disclosure of the study information | 2019/03/12 |
| Last modified on | 2020/02/04 15:12:45 |
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Basic information
Public title
Comparison of short-axis out-of-plane and long-axis in-plane ultrasound-guided central venous catheterization in pediatric patients: a randomized controlled trial
Acronym
Comparison of short-axis out-of-plane and long-axis in-plane ultrasound-guided central venous catheterization in pediatric
Scientific Title
Comparison of short-axis out-of-plane and long-axis in-plane ultrasound-guided central venous catheterization in pediatric
Scientific Title:Acronym
Comparison of short-axis out-of-plane and long-axis in-plane ultrasound-guided central venous catheterization in pediatric
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pediatric patients who underwent surgical operation under general anesthesia were randomely allocated in two groups, and underwent ultrasound-guided central venous catheterization in short-axis out-of-plane or long-axis in-plane techniques. We compared the rate of posterior wall puncture and successful catheterization.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of posterior wall puncture
Key secondary outcomes
First attempt success rate, overall success rate, procedure duration, number of attempt
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Maneuver |
Interventions/Control_1
We perform ultrasound-guided central venous catheterization with long-axis in-plane approach for intervention group.
Interventions/Control_2
We perform ultrasound-guided central venous catheterization with short-axis out-of-plane approach for control group.
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
| Not applicable |
Age-upper limit
| 5 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pediatric patients, who are under 5 years old and underwent surgical operation, underwent central venous catheteriation via internal jugular vein after induction of general anesthesia at the operation room of Osaka Women's and Children's hospital.
Key exclusion criteria
Patients whose parents do not agree with this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Takeshita |
Organization
Osaka Women's and Children's Hospital
Division name
Department of Intensive Care Medicine
Zip code
594-1101
Address
840 Murodo-cho, Izumi, Osaka 594-1101, Japan
TEL
0725561220
t-k-s-t@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Takeshita |
Organization
Osaka Women's and Children's Hospital
Division name
Department of Intensive Care Medicine
Zip code
594-1101
Address
840 Murodo-cho, Izumi, Osaka 594-1101, Japan
TEL
0725561220
Homepage URL
t-k-s-t@koto.kpu-m.ac.jp
Sponsor or person
Institute
Osaka Women's and Children's 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)
IRB Contact (For public release)
Organization
IRB of Osaka Women's and Children's Hospital
Address
840 Murodo-cho, Izumi, Osaka 594-1101, Japan
Tel
0725561220
kimi-h-u@wch.opho.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
| 2019 | Year | 03 | Month | 12 | 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
100
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
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 03 | Month | 12 | Day |
Last modified on
| 2020 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041208
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
