UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039387
Receipt No. 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 2020/02/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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
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 Open public recruiting
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
2020 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.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


Contact us.