UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014730 |
|---|---|
| Receipt number | R000017125 |
| Scientific Title | Ultrasound-guided vs. conventional peripheral intravenous access placement in pediatric emergency room in Japan: A non-randomized parallel group study. |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2014/08/06 22:00:08 |
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Basic information
Public title
Ultrasound-guided vs. conventional peripheral intravenous access placement in pediatric emergency room in Japan: A non-randomized parallel group study.
Acronym
Ultrasound-guided vs. conventional peripheral intravenous access placement in pediatric emergency room in Japan: A non-randomized parallel group study.
Scientific Title
Ultrasound-guided vs. conventional peripheral intravenous access placement in pediatric emergency room in Japan: A non-randomized parallel group study.
Scientific Title:Acronym
Ultrasound-guided vs. conventional peripheral intravenous access placement in pediatric emergency room in Japan: A non-randomized parallel group study.
Region
| Japan |
Condition
Condition
intravenous infusion
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to evaluate superiority of ultrasonography(US)-guided IV access over conventional IV access.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Difference in the rate of successful IV access placement in conventional method and in US-guided method.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Device,equipment | Maneuver |
Interventions/Control_1
intravenous access placement with US guidance
Interventions/Control_2
Intravenous access placement with conventional method
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
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Visit ER from 9 AM to 5 PM through Monday to Friday (National holiday excluded).
2. Age less than 16 years old
3. IV access is warranted and senior residents attempted the initial procedure.
4. Informed consent to participate in the study was given by patients or their guardians with full understanding of the methods, merits, and demerits of the study.
Key exclusion criteria
1. Be evaluated as blue triage based on JTAS triage or similar conditions at the initial triage (unstable breathing or circulation which needs emergent intervention)
2. The doctor in charge of the study or the doctors in alliance with the study decide not to include the participants to the study.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiro Hasegawa |
Organization
Tokyo Metropolitan Children Medical Center
Division name
Department of General Pediatrics
Zip code
Address
2-8-29 Mushashidai Fuchu-city Tokyo Japan
TEL
042-300-5111
yukihiro_hasegawa@tmhp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehito Otani |
Organization
Tokyo Metropolitan Children Medical Center
Division name
Department of General Pediatrics
Zip code
Address
2-8-29 Mushashidai Fuchu-city Tokyo Japan
TEL
042-300-5111
Homepage URL
takehito_ohtani@tmph.jp
Sponsor or person
Institute
Tokyo Metropolitan Children Medical Center
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
H26-8
Org. issuing International ID_1
Tokyo Metropolitan Children Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京都立小児総合医療センター Tokyo Metropolitan Children’s Medical Center
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 01 | 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
| 2014 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | 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
| 2014 | Year | 07 | Month | 31 | Day |
Last modified on
| 2014 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017125
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
