UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of ultrasound-guided peripheral intravenous catheter placement with infants(cleft lip and palate)
Title of the study (Brief title)	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	Mitsuharu Ino
Organization	Toyohashi Municipal Hospital
Division name	Department of Anesthesiology
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	Mitsuharu Ino
Organization	Toyohashi Municipal Hospital
Division name	Department of Anesthesiology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 01 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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