UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009803 |
|---|---|
| Receipt number | R000011481 |
| Scientific Title | Ultrasound-guided radial arterial catheterization and peripheral venous access in pediatric patients |
| Date of disclosure of the study information | 2013/01/18 |
| Last modified on | 2013/07/08 14:04:17 |
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Basic information
Public title
Ultrasound-guided radial arterial catheterization and peripheral venous access in pediatric patients
Acronym
Ultrasound-guided radial arterial catheterization and peripheral venous access in pediatric patients
Scientific Title
Ultrasound-guided radial arterial catheterization and peripheral venous access in pediatric patients
Scientific Title:Acronym
Ultrasound-guided radial arterial catheterization and peripheral venous access in pediatric patients
Region
| Japan |
Condition
Condition
elective surgery in pediatirc patinets
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish new methods of ultrasound-guided radial artery catheterization and peripheral venous access in pediatirc patinets
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
catheterization time,
number of attempts,
success rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Group1:conventional method 1
Interventions/Control_2
Group2:conventional method 2
Interventions/Control_3
Group3:new method
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
| 0 | months-old | < |
Age-upper limit
| 60 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Pediatric patinets are performed elective surgery in operating room of University hospital,Kyoto Prefectural University of Medicine
Key exclusion criteria
abnormal Allen test
congenital aortic disease (coarctation of aorta, patent ductus arteriosus) and
malformation of forearm arteries (hypoplastic or absent) during pre-scan with
ultrasound.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiki Mizobe |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Anesthesiology
Zip code
Address
Department of Anesthesiology, Kyoto Prefectural University of Medicine, Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Anesthesiology
Zip code
Address
TEL
075-251-5633
Homepage URL
Sponsor or person
Institute
Kyoto Prefectural University of Medicine,Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for Promotion of Science
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 01 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 20 | 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
| 2013 | Year | 01 | Month | 18 | Day |
Last modified on
| 2013 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011481
