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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025136
Receipt No. R000028906
Scientific Title The examination of the factor to affect the difficulty of radial artery catheter placement and the analysis of substitute artery of the upper extremity used instead of the radial artery using the ultrasound device
Date of disclosure of the study information 2016/12/04
Last modified on 2019/12/09

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Basic information
Public title The examination of the factor to affect the difficulty of radial artery catheter placement and the analysis of substitute artery of the upper extremity used instead of the radial artery using the ultrasound device
Acronym The examination of the factor to affect the difficulty of radial artery catheter placement and the analysis of substitute artery of the upper extremity used instead of the radial artery using the ultrasound device
Scientific Title The examination of the factor to affect the difficulty of radial artery catheter placement and the analysis of substitute artery of the upper extremity used instead of the radial artery using the ultrasound device
Scientific Title:Acronym The examination of the factor to affect the difficulty of radial artery catheter placement and the analysis of substitute artery of the upper extremity used instead of the radial artery using the ultrasound device
Region
Japan

Condition
Condition The patient scheduled for surgery who requires the artery catheter placement
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Hematology and clinical oncology
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Chest surgery Endocrine surgery
Breast surgery Obsterics and gynecology Pediatrics
Ophthalmology Dermatology Psychiatry
Oto-rhino-laryngology Orthopedics Urology
Radiology Anesthesiology Oral surgery
Neurosurgery Cardiovascular surgery Plastic surgery
Aesthetic surgery Laboratory medicine Operative medicine
Emergency medicine Blood transfusion Intensive care medicine
Rehabilitation medicine Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This reseach is performed to examine a factor to affect the difficulty of the artery catheter placement and substitute artery of the upper extremity.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We evaluate the following items after the artery catheter placement.
1) Patient back ground
2) Operator background
3) The situation of artery catheter placement
Key secondary outcomes The running confirmation and the measurement blood flow velocity and volume of radial artery and substitute artery

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 We perform the examination of ultrasonography and near infrated inspection of the artery of the upper extremity in the perioperative period
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 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patient scheduled for surgery who requires the artery catheter placement
Key exclusion criteria The ineligible patinet to attend judged by a doctor in attendance
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Tetsuya
Middle name
Last name Uchino
Organization Faculty of Medicine, Oita University
Division name Department of Anesthesiology
Zip code 879-5503
Address 1-1, Idaigaoka, Hazamacho, Yufushi, Oita, Japan
TEL 097-586-5943
Email utetsuya@oita-u.ac.jp

Public contact
Name of contact person
1st name Tetsuya
Middle name
Last name Tetsuya
Organization Faculty of Medicine, Oita University
Division name Department of Anesthesiology
Zip code 879-5503
Address 1-1, Idaigaoka, Hazamacho, Yufushi, Oita, Japan
TEL 097-586-5943
Homepage URL
Email utetsuya@oita-u.ac.jp

Sponsor
Institute Oita University
Institute
Department

Funding Source
Organization Oita University
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 Ethical Committee of Oita University Faculty of Medicine
Address 1-1, Idaigaoka, Hazamacho, Yufushi, Oita, Japan
Tel 097-586-5125
Email rinrikenkyu@oita-u.ac.jp

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 12 Month 04 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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 01 Day
Date of IRB
2016 Year 07 Month 21 Day
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
2021 Year 07 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 12 Month 04 Day
Last modified on
2019 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028906

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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