UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034909 |
|---|---|
| Receipt number | 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 12:38:50 |
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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
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
inou-mitsuharu@toyohashi-mh.jp
Sponsor or person
Institute
Toyohashi Municipal Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039776
