UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033078 |
|---|---|
| Receipt number | 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 | 2021/12/22 15:29:45 |
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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 | Tomonari |
| Middle name | |
| Last name | Shinozaki |
Organization
Miyagi Children's Hospital
Division name
Anesthesiology
Zip code
9893126
Address
4-3-17 Ochiai, Aoba-ku, Sendai
TEL
022-391-5111
tmn316@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tomonari |
| Middle name | |
| Last name | Shinozaki |
Organization
Miyagi Children's Hospital
Division name
Anesthesiology
Zip code
9893126
Address
4-3-17 Ochiai, Aoba-ku, Sendai
TEL
022-391-5111
Homepage URL
tmn316@yahoo.co.jp
Sponsor or person
Institute
Miyagi Children's Hospital
Institute
Department
Personal name
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
Miyagi Children's Hospital
Address
4-3-17 Ochiai, Aoba-ku, Sendai
Tel
022-391-5111
kei.nakai@miyagi-children.or.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
| 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
Main results already published
Date of protocol fixation
| 2017 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 13 | Day |
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
| 2021 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037706
