UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of Mill Suss-guided radial artery catheterization in eldery patients.
Acronym	Efficacy of Mill Suss-guided radial artery catheterization in eldery patients.
Scientific Title	Efficacy of Mill Suss-guided radial artery catheterization in eldery patients.
Scientific Title:Acronym	Efficacy of Mill Suss-guided radial artery catheterization in eldery patients.
Region	Japan

Condition
Condition	The patients requirements for artery catheterization
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of Ultrasound-guided and Ultrasound -guided with Mill Suss radial artery catheterization in eldery patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	First-attempt success rate of radial artery catheterization
Key secondary outcomes	The number of attempts to success of radial artery catheterization, The time to success of radial artery cathterization, the difficulty ofcatheterization, and complications

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	Echo group: Get the concent from the patients one day before operation and arterial catheterization operation day.
Interventions/Control_2	Echo with Mill Suss group:Get the concent from the patients one day before operation and arterial catheterization 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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients who are ASA PS 1-3.
Key exclusion criteria	Dialysis patients Peripheral artery disease patients
Target sample size	56

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Maruyama
Organization	Shinshu university school of medicine
Division name	The department of anesthesiology resuscitology
Zip code	390-8621
Address	Matsumoto, Nagano Prefecture Asahi 3-1-1
TEL	0263372670
Email	y5maruyama@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Maruyama
Organization	Shinshu university school of medicine
Division name	The department of anesthesiology resuscitology
Zip code	390-8621
Address	Matsumoto, Nagano Prefecture Asahi 3-1-1
TEL	0263372670
Homepage URL
Email	y5maruyama@shinshu-u.ac.jp

Sponsor
Institute	Shinshu university school
Institute
Department

Funding Source
Organization	Shinshu university school
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	The department of anesthesiology resuscitology,shinshu university school of medicine
Address	Matsumoto, Nagano Prefecture Asahi 3-1-1
Tel	0263372670
Email	y5maruyama@shinshu-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 06 Month 27 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	52
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	No longer recruiting
Date of protocol fixation	2016 Year 06 Month 06 Day
Date of IRB	2016 Year 06 Month 27 Day
Anticipated trial start date	2016 Year 06 Month 27 Day
Last follow-up date	2021 Year 06 Month 27 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 06 Month 23 Day
Last modified on	2019 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026348