UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039387
Receipt number R000044907
Scientific Title Combined short-axis out-of-plane and long-axis in-plane approach versus long-axis in-plane approach for ultrasound-guided central venous catheterization in pediatric patients: a randomized controlled trial
Date of disclosure of the study information 2020/02/04
Last modified on 2022/02/05 09:28:02

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Basic information

Public title

Combined short-axis out-of-plane and long-axis in-plane approach versus long-axis in-plane approach for ultrasound-guided central venous catheterization in pediatric patients: a randomized controlled trial

Acronym

Combined short-axis out-of-plane and long-axis in-plane approach versus long-axis in-plane approach for ultrasound-guided central venous catheterization in pediatric patients: a randomized controlled trial

Scientific Title

Combined short-axis out-of-plane and long-axis in-plane approach versus long-axis in-plane approach for ultrasound-guided central venous catheterization in pediatric patients: a randomized controlled trial

Scientific Title:Acronym

Combined short-axis out-of-plane and long-axis in-plane approach versus long-axis in-plane approach for ultrasound-guided central venous catheterization in pediatric patients: a randomized controlled trial

Region

Japan


Condition

Condition

none

Classification by specialty

Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Pediatric patients who underwent surgical operation under general anesthesia were randomly allocated in two groups, and underwent ultrasound-guided central venous catheterization using combined short-axis out-of-plane and long-axis in-plane approach or long-axis in-plane approach. We compare the rate of posterior wall puncture and successful catheterization.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Posterior wall puncture rate.

Key secondary outcomes

First attempt success rate, overall success rate, procedural duration, number of puncture.


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 internal jugular vein puncture using combined long-axis and short-axis approach.

Interventions/Control_2

We perform ultrasound-guided internal jugular vein puncture using long-axis approach.

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, undergo surgical operation, and require central venous 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

110


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

5941101

Address

840 Murodo-cho, Izumi, Osaka

TEL

0725561220

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

5941101

Address

840 Murodo-cho, Izumi, Osaka

TEL

0725561220

Homepage URL


Email

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


Sponsor or person

Institute

Department of Anesthesiology, Osaka women's and Children's Hospital

Institute

Department

Personal name



Funding Source

Organization

self funding

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

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

2020 Year 02 Month 04 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

110

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

2020 Year 01 Month 31 Day

Date of IRB

2020 Year 01 Month 31 Day

Anticipated trial start date

2020 Year 02 Month 04 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 02 Month 04 Day

Last modified on

2022 Year 02 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044907


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name