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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042847
Receipt No. R000048911
Scientific Title Comparison of radial, posterior tibial and dorsalis pedis arteries for ultrasound-guided arterial catheterization with dynamic needle tip positioning in pediatric patients: a randomized controlled trial
Date of disclosure of the study information 2020/12/25
Last modified on 2020/12/25

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Basic information
Public title Comparison of radial, posterior tibial and dorsalis pedis arteries for ultrasound-guided arterial catheterization with dynamic needle tip positioning in pediatric patients: a randomized controlled trial
Acronym Comparison of radial, posterior tibial and dorsalis pedis arteries for ultrasound-guided arterial catheterization with dynamic needle tip positioning in pediatric patients: a randomized controlled trial
Scientific Title Comparison of radial, posterior tibial and dorsalis pedis arteries for ultrasound-guided arterial catheterization with dynamic needle tip positioning in pediatric patients: a randomized controlled trial
Scientific Title:Acronym Comparison of radial, posterior tibial and dorsalis pedis arteries for ultrasound-guided arterial catheterization with dynamic needle tip positioning in pediatric patients: a randomized controlled trial
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 randomly allocated in three groups, and underwent ultrasound-guided arterial catheterization using dynamic needle tip positioning. We compare the first attempt and overall success rates, number of attempts and procedure duration.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes First attempt success rate
Key secondary outcomes Overall success rate, number of attempts, procedure duration

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 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Arterial catheterization for radial artery.
Interventions/Control_2 Arterial catheterization for posterior tibial artery.
Interventions/Control_3 Arterial catheterization for dorsalis pedis artery.
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
3 years-old >
Gender Male and Female
Key inclusion criteria Pediatric patients who are under 3 years old, undergo surgical operation, and require arterial catheter insertion in Osaka Women's and Children's hospital.
Key exclusion criteria Patients whose parents do not agree with this study.
Target sample size 198

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
TEL 0725-56-1220
Email t-k-s-@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
TEL 0725-56-1220
Homepage URL
Email t-k-s-@koto.kpu-m.ac.jp

Sponsor
Institute Department of Anesthesiology, Osaka Women's and Children's Hospital
Institute
Department

Funding Source
Organization None
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
Tel 0725-56-1220
Email 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
2020 Year 12 Month 25 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
2020 Year 12 Month 25 Day
Date of IRB
2020 Year 12 Month 25 Day
Anticipated trial start date
2020 Year 12 Month 28 Day
Last follow-up date
2023 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
2020 Year 12 Month 25 Day
Last modified on
2020 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048911

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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