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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021546
Receipt No. R000024843
Scientific Title The Usefulness of Mill Suss-guided radial artery catheterization compared with ultrasound-guided catheterization
Date of disclosure of the study information 2016/03/21
Last modified on 2018/06/24

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Basic information
Public title The Usefulness of Mill Suss-guided radial artery catheterization compared with ultrasound-guided catheterization
Acronym The Usefulness of Mill Suss-guided radial artery catheterization compared with ultrasound-guided catheterization
Scientific Title The Usefulness of Mill Suss-guided radial artery catheterization compared with ultrasound-guided catheterization
Scientific Title:Acronym The Usefulness of Mill Suss-guided radial artery catheterization compared with ultrasound-guided catheterization
Region
Japan

Condition
Condition the patients who has to perform radial artery catheterization
Classification by specialty
Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to examine the usefulness of Mill Suss, which is the device for visualization of radial artery, guided radial artery catheterization compared with ultrasound-guided catheterization
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the number of times required for radial artery catheterization, time required for catheterization
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Mii Suss group (2 days from one day before operation to operation day)
Interventions/Control_2 Ultrasound group (2 days from one day before operation to operation day)
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria The patients who has ASA-PS I to III and required to perform radial artery catheterization
Key exclusion criteria the patients who has difficulty in mutual understanding and has difficulty to get cooperation
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsutaka Edanaga
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code
Address S1, W16, Chuo-ku, Sapporo
TEL 011-688-9663
Email edanaka@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kouji Hamaya
Organization Sapporo Medical University School of Medicine
Division name Hospital section
Zip code
Address S1, W16, Chuo-ku, Sapporo
TEL 011-611-2111
Homepage URL
Email ko-hamaya-923@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization Department of Anesthesiology, 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
Address
Tel
Email

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
2016 Year 03 Month 21 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 Completed
Date of protocol fixation
2015 Year 12 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 22 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
2016 Year 03 Month 19 Day
Last modified on
2018 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024843

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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