UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037874 |
|---|---|
| Receipt number | R000043178 |
| Scientific Title | Dynamic needle tip positioning for ultrasound-guided catheterization of posterior tibial or dorsalis pedis arteries in pediatric patients: a randomized control trial |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2020/12/25 13:37:07 |
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Basic information
Public title
Dynamic needle tip positioning for ultrasound-guided catheterization of posterior tibial or dorsalis pedis arteries in pediatric patients: a randomized control trial
Acronym
Dynamic needle tip positioning for ultrasound-guided catheterization of posterior tibial or dorsalis pedis arteries in pediatric patients: a randomized control trial
Scientific Title
Dynamic needle tip positioning for ultrasound-guided catheterization of posterior tibial or dorsalis pedis arteries in pediatric patients: a randomized control trial
Scientific Title:Acronym
Dynamic needle tip positioning for ultrasound-guided catheterization of posterior tibial or dorsalis pedis arteries in pediatric patients: a randomized control trial
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We perform posterior tibial or dorsalis pedis arterial catheterization with or without ultrasound guidance (using DNTP). We compare first attempt success rate, overall success rate, procedural duration, number of puncture, posterior wall puncture between two groups.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
First attempt success rate.
Key secondary outcomes
Overall success rate, procedural duration, number of puncture, posterior wall puncture, vascular diameter and vascular depth.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Puncture posterior tibial arteries by using ultrasound-guided dynamic needle tip positioning.
Interventions/Control_2
Puncture dorsalis pedis arteries by using ultrasound-guided dynamic needle tip positioning.
Interventions/Control_3
Puncture posterior tibial arteries by using palpation technique.
Interventions/Control_4
Puncture dorsalis pedis arteries by using palpation technique.
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
| 3 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pediatric patients who are under 3 years old, undergo a cardiovascular surgery, and require arterial catheter insertion at Osaka Women's and Children's hospital.
Key exclusion criteria
Patients whose parents do not agree with this study.
Target sample size
140
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 Anesthesiology
Zip code
594-1101
Address
840 Murodo-cho, Izumi, Osaka 594-1101, Japan
TEL
0725-56-1220
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 Anesthesiology
Zip code
594-1101
Address
840 Murodo-cho, Izumi, Osaka 594-1101, Japan
TEL
0725-56-1220
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
Osaka Women's and Children's Hospital
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
IRB of Osaka Women's and Children's Hospital
Address
840 Murodo-cho, Izumi, Osaka
Tel
0725-56-1220
kimi-h-u@mch.pref.osaka.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 | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
140
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 | 08 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 09 | 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
Management information
Registered date
| 2019 | Year | 08 | Month | 31 | Day |
Last modified on
| 2020 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043178
