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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012880
Receipt No. R000015048
Scientific Title Examination of procedures for the establishment of accurate and safe ultrasound-guided central venous catheterization in pediatric patient
Date of disclosure of the study information 2014/01/16
Last modified on 2014/01/16

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Basic information
Public title Examination of procedures for the establishment of accurate and safe ultrasound-guided central venous catheterization in pediatric patient
Acronym Ultrasound-guided internal jugular vein catheterization in pediatric patient by novice trainees: A pilot study using long-axis in plane technique with needle guide
Scientific Title Examination of procedures for the establishment of accurate and safe ultrasound-guided central venous catheterization in pediatric patient
Scientific Title:Acronym Ultrasound-guided internal jugular vein catheterization in pediatric patient by novice trainees: A pilot study using long-axis in plane technique with needle guide
Region
Japan

Condition
Condition Pediatric patient with congenital heart disease undergoing cardiac surgery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examining that three-step method can be applied to pediatric patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The number of trying skin stick up to success US-IJV
Complication (arterial puncture, pneumothorax, hematoma, etc.) and puncture of the posterior internal jugular vein wall
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 Before the clinical trial, all participants underwent hands-on training using a simulator to learn the three-step method technique of US-IJV
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

Not applicable
Gender Male and Female
Key inclusion criteria Pediatric patient with congenital heart disease undergoing cardiac surgery was considered for study enrollment
Key exclusion criteria Parents refuse to enroll in the study
Body weight < 5 kg
ASA physical status > 2
Size of right internal jugular vein (target vein) < 3 mm
Unsuitable right internal jugular vein for catheterization such as intravenous thrombosis and ectopic location
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Tadokoro
Organization Okinawa Prefectural Miyako Hospital
Division name Department of Anesthesia
Zip code
Address 427-1, Hirara Shimozato, Miyakojima-shi, Okinawa, 906-0013, Japan
TEL 08034237522
Email rover2727@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Tadokoro
Organization Okinawa Prefectural Miyako Hospital
Division name Department of Anesthesia
Zip code
Address 427-1, Hirara Shimozato, Miyakojima-shi, Okinawa, 906-0013, Japan
TEL 08034237522
Homepage URL
Email rover2727@yahoo.co.jp

Sponsor
Institute Department of Anesthesia, Medical Center & Children's Medical Center
Institute
Department

Funding Source
Organization none
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
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
2014 Year 01 Month 16 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 Completed
Date of protocol fixation
2013 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
2014 Year 07 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 16 Day
Last modified on
2014 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015048

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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