UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029882
Receipt number R000034134
Scientific Title Ultrasound guided radial artery catheterization with or without dynamic needle tip positioning for deep artery in pediatric patients: a randomized control trial
Date of disclosure of the study information 2017/11/08
Last modified on 2020/01/22 13:57:34

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Basic information

Public title

Ultrasound guided radial artery catheterization with or without dynamic needle tip positioning for deep artery in pediatric patients: a randomized control trial

Acronym

Ultrasound guided radial artery catheterization with or without dynamic needle tip positioning for deep artery in pediatric patients: a randomized control trial

Scientific Title

Ultrasound guided radial artery catheterization with or without dynamic needle tip positioning for deep artery in pediatric patients: a randomized control trial

Scientific Title:Acronym

Ultrasound guided radial artery catheterization with or without dynamic needle tip positioning for deep artery in pediatric patients: a randomized control trial

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 radial artery catheterization with or without 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 compare first attempt success rate, overall success rate, procedural duration, number of puncture, posterior wall puncture, vascular diameter and vascular depth between two groups.

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, 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

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

We perform ultrasound guided radial arterial catheterization with DNTP for intervation group.

Interventions/Control_2

We perform ultrasound guided radial arterial catheterization without DNTP 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

3 years-old >

Gender

Male and Female

Key inclusion criteria

Pediatric patients who are under 3 years old, admit to PICU of Osaka Women's and Children's hospital, require arterial catheter insertion and whose arterial depth is over 4mm.

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 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

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 11 Month 01 Day

Date of IRB

2017 Year 11 Month 01 Day

Anticipated trial start date

2017 Year 11 Month 08 Day

Last follow-up date

2019 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

2017 Year 11 Month 08 Day

Last modified on

2020 Year 01 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034134


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name