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
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
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
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
