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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033078
Receipt No. R000037706
Scientific Title Is T-shaped probe HS1600 useful in pediatric ultrasound-guided internal jugular vein puncture?
Date of disclosure of the study information 2018/06/25
Last modified on 2018/06/22

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Basic information
Public title Is T-shaped probe HS1600 useful in pediatric ultrasound-guided internal jugular vein puncture?
Acronym Is T-shaped probe useful in pediatric ultrasound-guided internal jugular vein puncture?
Scientific Title Is T-shaped probe HS1600 useful in pediatric ultrasound-guided internal jugular vein puncture?
Scientific Title:Acronym Is T-shaped probe useful in pediatric ultrasound-guided internal jugular vein puncture?
Region
Japan

Condition
Condition the cases with scheduled puncture of internal jugular vein for surgery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate a success rate and a method in pediatric ultrasound guided internal jugular vein puncture with T-shaped probe of ultrasound device HS1600 which simultaneously provide both a short axis and a long axis view in comparison with a habitual used probe.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.a success rate of the first internal jugular vein puncture
Key secondary outcomes 1.an angle of skin puncture
2.a distance from skin puncture site to vein puncture site

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 T-shaped probe (interventional group)
Interventions/Control_2 habitual used probe (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
6 years-old >
Gender Male and Female
Key inclusion criteria scheduled cases which anesthsiologists puncture right internal jugular vein with ultrasound guide
Key exclusion criteria 1. cases which doctors except anesthesiologists puncture right internal jugular vein
2. cases with scheduled central vein puncture except right internal jugular vein
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonari Shinozaki
Organization Miyagi Children's Hospital
Division name Anesthesiology
Zip code
Address 4-3-17 Ochiai, Aoba-ku, Sendai
TEL 022-391-5111
Email tmn316@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomonari Shinozaki
Organization Miyagi Children's Hospital
Division name Anesthesiology
Zip code
Address 4-3-17 Ochiai, Aoba-ku, Sendai
TEL 022-391-5111
Homepage URL
Email tmn316@yahoo.co.jp

Sponsor
Institute Miyagi Children's Hospital
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
2018 Year 06 Month 25 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
1. This study was approved by institutional review board in our hospital.
2. Although 17 children were enrolled in this study, one child was excluded due to planning to puncture left internal jugular vein at first. 16 children were assigned to either intervention group (T-shaped probe) or control group (a habitual used probe). Patient characteristics was not different between the two groups. 
3. A success rate of the first puncture was not different between the two groups: intervention group 63% versus control group 75%.
4. There were significant differences in an angle of skin puncture: intervention group 22.7 degrees (7.7-29.0) vs. control 36.9 degrees (30.9-43.9), p<0.05 and a distance from skin puncture site to vein puncture site: intervention group 20.1mm (14.0-37.9) vs. control group 12.0mm (10.0-13.9), p<0.05.
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
2017 Year 11 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 13 Day
Last follow-up date
2017 Year 12 Month 28 Day
Date of closure to data entry
2017 Year 12 Month 28 Day
Date trial data considered complete
2017 Year 12 Month 28 Day
Date analysis concluded
2018 Year 10 Month 20 Day

Other
Other related information

Management information
Registered date
2018 Year 06 Month 21 Day
Last modified on
2018 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037706

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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