UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the change in the femoral vein diameter due to lower limb flexion
Title of the study (Brief title)	Examination of the change in the femoral vein due to lower limb flexion
Region	Japan

Condition
Condition	Adult patients (ASA physical status I-II) scheduled for elective surgery under general anesthesia
Classification by specialty	Surgery in general Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the changes in the femoral vein(FV) diameter and positional relationship during the lower limb flexion by ultrasonographic apparatus
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	distance from skin to anterior wall of the FV, diameter between anterior and posterior wall of the FV, transverse diameter of the FV, exposed width of the FV (length not overlapped by the FA), transverse diameter of the FA
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	to investigate the changes in the FV diameter and positional relationship during the lower limb flexion by ultrasonographic apparatus
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	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	Adult patients (ASA physical status I-II, ) scheduled for elective surgery under general anesthesia
Key exclusion criteria	Patients with a history of hip joint disease
Target sample size	50

Research contact person
Name of lead principal investigator	Kimura Tetsuro
Organization	Hamamatsu University School of Medicine
Division name	Department of Anesthesiology and Intensive Care
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan
TEL	053-435-2286
Email	kimutetsuuu@hotmail.com

Public contact
Name of contact person	Kimura Tetsuro
Organization	Hamamatsu University School of Medicine
Division name	Department of Anesthesiology and Intensive Care
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan
TEL	053-435-2286
Homepage URL
Email	kimutetsuuu@hotmail.com

Sponsor
Institute	Department of Anesthesiology and Intensive Care, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	No source of funding
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	浜松医科大学医学部付属病院（静岡県）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 06 Day
Anticipated trial start date	2015 Year 01 Month 16 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 15 Day
Last modified on	2016 Year 09 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018827