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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034909
Receipt No. R000039776
Scientific Title Usefulness of ultrasound-guided peripheral intravenous catheter placement with infants(cleft lip and palate)
Date of disclosure of the study information 2018/11/16
Last modified on 2018/11/16

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Basic information
Public title Usefulness of ultrasound-guided peripheral intravenous catheter placement with infants(cleft lip and palate)
Acronym Usefulness of ultrasound-guided peripheral intravenous catheter placement with infants(cleft lip and palate)
Scientific Title Usefulness of ultrasound-guided peripheral intravenous catheter placement with infants(cleft lip and palate)
Scientific Title:Acronym Usefulness of ultrasound-guided peripheral intravenous catheter placement with infants(cleft lip and palate)
Region
Japan

Condition
Condition Infats with cleft lip and palate less than 12 months
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Peripheral intravenous catheter placement of infants(cleft lip and palate) is difficult.In this study,we clarify whether it is useful for improving the success rate of peripheral intravenous catheter placement by using ultrasound device
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The number of attempts at insertion of peripheral intravenous catheter placement
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1 months-old <=
Age-upper limit
12 months-old >=
Gender Male and Female
Key inclusion criteria 1.ASA-PS 1-2
2.Infants(cleft lip and palate) with planned lipplasty
3.Ultrasound guided cannulation of great saphenous vein at the ankle
Key exclusion criteria 1.Infants(cleft lip and palate) with Dehydrated
2.infants(cleft lip and palate) with severe heart disease
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuharu Ino
Organization Toyohashi Municipal Hospital
Division name Department of Anesthesiology
Zip code
Address 50 Aza Hachiken Nishi,Aotake-Cho,Toyohashi,Aichi
TEL 0532-33-6111
Email inou-mitsuharu@toyohashi-mh.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuharu Ino
Organization Toyohashi Municipal Hospital
Division name Department of Anesthesiology
Zip code
Address 50 Aza Hachiken Nishi,Aotake-Cho,Toyohashi,Aichi
TEL 0532-33-6111
Homepage URL
Email inou-mitsuharu@toyohashi-mh.jp

Sponsor
Institute Toyohashi Municipal Hospital
Institute
Department

Funding Source
Organization Toyohashi Municipal Hospital
Organization
Division
Category of Funding Organization Local Government
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 11 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 Enrolling by invitation
Date of protocol fixation
2017 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective study

Management information
Registered date
2018 Year 11 Month 16 Day
Last modified on
2018 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039776

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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