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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014730
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email takehito_ohtani@tmph.jp

Sponsor
Institute Tokyo Metropolitan Children Medical Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017125


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