UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023522 |
|---|---|
| Receipt number | R000027094 |
| Scientific Title | Comparison of the usefulness of Mill Suss-guided peripheral venous catheterization of pediatric patients under general anesthesia with direct venous puncture methods |
| Date of disclosure of the study information | 2016/08/07 |
| Last modified on | 2019/04/16 06:45:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of the usefulness of Mill Suss-guided peripheral venous catheterization of pediatric patients under general anesthesia with direct venous puncture methods
Acronym
Comparison of the usefulness of Mill Suss-guided peripheral venous catheterization of pediatric patients under general anesthesia with direct venous puncture methods
Scientific Title
Comparison of the usefulness of Mill Suss-guided peripheral venous catheterization of pediatric patients under general anesthesia with direct venous puncture methods
Scientific Title:Acronym
Comparison of the usefulness of Mill Suss-guided peripheral venous catheterization of pediatric patients under general anesthesia with direct venous puncture methods
Region
| Japan |
Condition
Condition
pediatric patients proposed operation
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the usefulness of Mill Suss-guided peripheral venous catheterization of pediatric patients under general anesthesia compared with direct venous puncture methods.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the number of puncture, the time to insert successfully
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
direct venous puncuture group (for 2 days)
Interventions/Control_2
Mil Suss-guided venous catheterization group (for 2 days)
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 | days-old | <= |
Age-upper limit
| 2190 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
periatric patients proposed operation
Key exclusion criteria
when the agreement is not provided, and the withdrawal of the agreement is recognized
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Edanaga |
| Middle name | |
| Last name | Mitsutaka |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
060-8543
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-688-9663
edanaka@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takeda |
Organization
Sapporo Medical University School of Medicine
Division name
Hospital section
Zip code
060-8543
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
hiroshi.takeda@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine
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
Hospital section
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
011-611-2111
hiroshi.takeda@sapmed.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
1704
Org. issuing International ID_1
Tomakomai City Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 07 | 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
37
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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 06 | Day |
Last modified on
| 2019 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027094
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
