UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The change in peripheral arterial blood flow with the placement of cannula into radial artery in the area of anesthesia and intensive care.
Title of the study (Brief title)	Cannulation into radial artery and blood flow
Region	Japan

Condition
Condition	Perioperative cases
Classification by specialty	Anesthesiology Intensive care medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The assessment of radial arterial cannulation on the peripheral arterial blood flow and the analysis of the safety.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The change in the blood flow measured by ultrasound sonography
Key secondary outcomes	The rate of complication

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	The artery of patients are cannulated with 20 G catheter.
Interventions/Control_2	The artery of patients are cannulated with 22 G catheter.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Post-surgical patients
Key exclusion criteria	The patients with severe cardiovascular complication. The patients with difficulty for measurement of blood flow using ultrasound sonography because of any inconveniences
Target sample size	80

Research contact person
Name of lead principal investigator	Yushi Adachi
Organization	Tokyo Medical and Dental University
Division name	Department of Intensive Care Medicine
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	+81358035959
Email	yuadachi.ccm@tmd.ac.jp

Public contact
Name of contact person	Yushi Adachi
Organization	Tokyo Medical and Dental University
Division name	Department of Intensive Care Medicine
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	+81358035959
Homepage URL
Email	yuadachi.ccm@tmd.ac.jp

Sponsor
Institute	Department of Intensive Care Medicine
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 11 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 11 Day
Anticipated trial start date	2015 Year 11 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 11 Month 11 Day
Last modified on	2017 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022810