UMIN-CTR Clinical Trial

Basic information
Public title	Ultrasound-guided radial artery cannulation using dynamic needle tip positioning technique versus long-axis in-plane techniques in adult surgical patients: a rondomized control trial
Acronym	Ultrasound-guided radial artery cannulation using dynamic needle tip positioning technique versus long-axis in-plane techniques in adult surgical patients: a rondomized control trial
Scientific Title	Ultrasound-guided radial artery cannulation using dynamic needle tip positioning technique versus long-axis in-plane techniques in adult surgical patients: a rondomized control trial
Scientific Title:Acronym	Ultrasound-guided radial artery cannulation using dynamic needle tip positioning technique versus long-axis in-plane techniques in adult surgical patients: a rondomized control trial
Region	Japan

Condition
Condition	none
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We perform ultrasound-guided radial artery cannulation using dynamic needle tip positioning technique or long-axis in-plane technique. We compare first attempt success rate , time variables, number of puncture attempts, posterior wall puncture rate and complication.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	first attempt success rate
Key secondary outcomes	time variables, number of puncture attempts, posterior wall puncture rate and complication

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	Maneuver
Interventions/Control_1	cannulation using dynamic needle tip positioning technique
Interventions/Control_2	cannulation using long-axis in-plane technique
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who undergo surgery and require radial artery cannulation
Key exclusion criteria	Body Mass Index >35kg/m2, upper limb edema, in shock, peripheral vascular desease, lack of patients content
Target sample size	180

Research contact person
Name of lead principal investigator	1st name Shinichi Middle name Last name Inomata
Organization	University of Tsukuba Hospital
Division name	Department of Anesthesia
Zip code	305-8576
Address	2-1-1, Amakubo, Tsukuba, Ibaraki
TEL	029-853-3900
Email	inomatas@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Yuto Middle name Last name Hamaguchi
Organization	University of Tsukuba Hospital
Division name	Department of Anesthesia
Zip code	305-8576
Address	2-1-1, Amakubo, Tsukuba, Ibaraki
TEL	029-853-3900
Homepage URL
Email	yhamaguchi-tuk@umin.ac.jp

Sponsor
Institute	University of Tsukuba Hospital
Institute
Department

Funding Source
Organization	University of Tsukuba Hospital
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	University of Tsukuba Hospital
Address	2-1-1, Amakubo, Tsukuba, Ibaraki
Tel	029-853-3900
Email	t-credo.adm@un,tsukuba.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	2019 Year 11 Month 20 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	Preinitiation
Date of protocol fixation	2019 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date	2019 Year 11 Month 20 Day
Last follow-up date	2021 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	2019 Year 10 Month 15 Day
Last modified on	2019 Year 10 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043649