UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The disturbing factors for residents to insert arterial catheter.
Title of the study (Brief title)	The study of arterial catheter insertion.
Region	Japan

Condition
Condition	The patients inserting arterial catheter
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The inserting arterial catheter is not easy for residents. The aim of this study is to reveal the factors disturbing for residents to insert arterial catheter.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The time needed to insert arterial catheter.
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	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Insert arterial catheter with sphygmopalpation
Interventions/Control_2	Insert arterial catheter with infrared light device "MillSuss"
Interventions/Control_3	Insert arterial catheter with ultrasound scan
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	The patients scheduled to insert arterial catheter under general anesthesia.
Key exclusion criteria	Emergency surgery Under 20 years old The patients inserting arterial catheter before general anesthesia The patients assessed inappropriate cases
Target sample size	150

Research contact person
Name of lead principal investigator	Irie Tomoya
Organization	Yokohama City University School of medicine
Division name	Department of Anesthesiology
Address	3-9, Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2918
Email	tomoya.irie0216@gmail.com

Public contact
Name of contact person	Irie Tomoya
Organization	Yokohama City University School of medicine
Division name	Department of Anesthesiology
Address	3-9, Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2918
Homepage URL
Email	tomoya.irie0216@gmail.com

Sponsor
Institute	Yokohama City University School of Medicine Department of Anesthesiology
Institute
Department

Funding Source
Organization	Department fund
Organization
Division
Category of Funding Organization	Self funding
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	横浜市立大学附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 22 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 12 Month 25 Day
Anticipated trial start date	2016 Year 01 Month 25 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 22 Day
Last modified on	2018 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023882