UMIN-CTR Clinical Trial

Basic information
Public title	Ultrasound guided puncture with dynamic needle tip positioning for peripherally inserted central catheter in pediatric patients.
Acronym	Ultrasound guided puncture with dynamic needle tip positioning for peripherally inserted central catheter in pediatric patients.
Scientific Title	Ultrasound guided puncture with dynamic needle tip positioning for peripherally inserted central catheter in pediatric patients.
Scientific Title:Acronym	Ultrasound guided puncture with dynamic needle tip positioning for peripherally inserted central catheter in pediatric patients.
Region	Japan

Condition
Condition	none
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We perform ultrasound guided catheterization of peripherally inserted central catheter using dynamic needle tip positioning (DNTP) which is a modified version of the short-axis out of plane approach where the transducer and needle are alternately moved so that the needle tip is successively visible or invisible on the screen. We investigate first attempt success rate, overall success rate, procedural duration, number of puncture, whether DNTP was performed, posterior wall puncture, vascular diameter and vascular depth.
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, whether DNTP was performed, posterior wall puncture, vascular diameter and vascular depth.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	5 years-old >
Gender	Male and Female
Key inclusion criteria	Pediatric patients who are under 5 years old, admit to PICU of Osaka Women's and Children's hospital, and require PICC insertion.
Key exclusion criteria	Patients whose parents do not agree with this study.
Target sample size	40

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	5941101
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 Intensive Care Medicine
Zip code	5941101
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	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 Women's and Children's Hospital
Address	840 Murodo-cho, Izumi, Osaka
Tel	0725561220
Email	t-k-s-t@koto.kpu-m.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

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 08 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	40
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	2017 Year 10 Month 03 Day
Date of IRB	2017 Year 10 Month 03 Day
Anticipated trial start date	2017 Year 11 Month 08 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective observational study

Management information
Registered date	2017 Year 11 Month 08 Day
Last modified on	2020 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034130