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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023522
Receipt No. 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

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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
Email 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
Email hiroshi.takeda@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.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


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