UMIN-CTR Clinical Trial

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
Email	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
Email	t-k-s-t@koto.kpu-m.ac.jp

Sponsor
Institute	Osaka Women's and Children's Hospital
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043178