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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010919
Receipt No. R000012670
Scientific Title Observational study of efficacy of skin lifting contributing to a technical safety for vessel puncture or conduction anesthesia in preoperative patients using ultrasound method
Date of disclosure of the study information 2013/06/10
Last modified on 2013/06/10

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Basic information
Public title Observational study of efficacy of skin lifting contributing to a technical safety for vessel puncture or conduction anesthesia in preoperative patients using ultrasound method
Acronym Evaluation of efficacy of skin lifting at vessel puncture or conduction anesthesia using ultrasound method
Scientific Title Observational study of efficacy of skin lifting contributing to a technical safety for vessel puncture or conduction anesthesia in preoperative patients using ultrasound method
Scientific Title:Acronym Evaluation of efficacy of skin lifting at vessel puncture or conduction anesthesia using ultrasound method
Region
Japan

Condition
Condition preoperative patients receiving blood vessel puncture or nerve block
Classification by specialty
Anesthesiology Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety increase (increase of subcutaneous space around a vessel or a nerve) by skin lifting using surgical tape by ultrasound method
Basic objectives2 Others
Basic objectives -Others Laboratory equivalency
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change of distance and area of blood vessel or soft tissue before and after skin lifting
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria A. In-patients received vessel puncture before operation
B. In-patients received conduction anesthesia for operation
Key exclusion criteria 1. No written informed consent
2. Patient ineligible to the study based on investigator's decision
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Isao Haraga
Organization Fukuoka University
Division name Department of Anesthesiology
Zip code
Address 7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL 092-801-1011
Email

Public contact
Name of contact person
1st name
Middle name
Last name Isao Haraga
Organization Fukuoka University
Division name Department of Anesthesiology
Zip code
Address 7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL 092-801-1011
Homepage URL http://www.hop.fukuoka-u.ac.jp/rinshou/doctor/shounin.html
Email haraga_i@yahoo.co.jp

Sponsor
Institute Fukuoka University Department of Anesthesiology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 福岡大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 10 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 Enrolling by invitation
Date of protocol fixation
2013 Year 04 Month 17 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Case control

Blood vessel size or subcutaneous space around a nerve

Increase of size or space by skin lifting

Management information
Registered date
2013 Year 06 Month 10 Day
Last modified on
2013 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012670

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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