UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016225
Receipt number R000018827
Scientific Title Examination of the change in the femoral vein diameter due to lower limb flexion
Date of disclosure of the study information 2015/01/16
Last modified on 2016/09/30 23:35:39

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Basic information

Public title

Examination of the change in the femoral vein diameter due to lower limb flexion

Acronym

Examination of the change in the femoral vein due to lower limb flexion

Scientific Title

Examination of the change in the femoral vein diameter due to lower limb flexion

Scientific Title:Acronym

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

1st name
Middle name
Last name Kimura Tetsuro

Organization

Hamamatsu University School of Medicine

Division name

Department of Anesthesiology and Intensive Care

Zip code


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

1st name
Middle name
Last name Kimura Tetsuro

Organization

Hamamatsu University School of Medicine

Division name

Department of Anesthesiology and Intensive Care

Zip code


Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan

TEL

053-435-2286

Homepage URL


Email

kimutetsuuu@hotmail.com


Sponsor or person

Institute

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

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2014 Year 11 Month 06 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018827


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name