UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010961
Receipt number R000012830
Scientific Title Determination of most appropriate site for ultrasound-guided catheterization in pediatric patinets
Date of disclosure of the study information 2013/06/14
Last modified on 2015/02/07 10:54:23

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Basic information

Public title

Determination of most appropriate site for ultrasound-guided catheterization in pediatric patinets

Acronym

Determination of most appropriate site for ultrasound-guided catheterization in pediatric patinets

Scientific Title

Determination of most appropriate site for ultrasound-guided catheterization in pediatric patinets

Scientific Title:Acronym

Determination of most appropriate site for ultrasound-guided catheterization in pediatric patinets

Region

Japan


Condition

Condition

elective surgery in pediatirc patinets

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To Determine the most appropriate site for ultrasound-guided catheterization in pediatric patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

catheterization time,
number of attempts,
success rate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Ultrasound-guided peripheral catheterization in cephalic veins at forearm

Interventions/Control_2

Ultrasound-guided peripheral catheterization in great saphenous veins at ankle

Interventions/Control_3

Ultrasound-guided peripheral catheterization in dorsal veins of hand

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

0 months-old <=

Age-upper limit

120 months-old >=

Gender

Male and Female

Key inclusion criteria

Pediatric patinets are performed elective surgery in operating room of University hospital,Kyoto Prefectural University of Medicine

Key exclusion criteria

The patients without informed consent

Target sample size

196


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiki Mizobe

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Anesthesiology

Zip code


Address

Department of Anesthesiology, Kyoto Prefectural University of Medicine, Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566

TEL

075-251-5633

Email

toshim@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshinobu Nakayama

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Anesthesiology

Zip code


Address

Department of Anesthesiology, Kyoto Prefectural University of Medicine, Kawaramachi Hirokoji, Kamigy

TEL

075-251-5633

Homepage URL


Email

na-yoshi@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine,Department of Anesthesiology

Institute

Department

Personal name



Funding Source

Organization

Japan Society for Promotion of Science

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


Address


Tel


Email



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

2013 Year 06 Month 14 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

No longer recruiting

Date of protocol fixation

2013 Year 01 Month 10 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 06 Month 14 Day

Last modified on

2015 Year 02 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012830


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name