UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051664 |
|---|---|
| Receipt number | R000058957 |
| Scientific Title | Peripheral Venous Dilation Using Blood Flow-Dependent Vasodilation Response |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2024/09/25 10:43:53 |
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Basic information
Public title
Peripheral Venous Dilation Using Blood Flow-Dependent Vasodilation Response
Acronym
Peripheral Venous Dilation Using Blood Flow-Dependent Vasodilation Response
Scientific Title
Peripheral Venous Dilation Using Blood Flow-Dependent Vasodilation Response
Scientific Title:Acronym
Peripheral Venous Dilation Using Blood Flow-Dependent Vasodilation Response
Region
| Japan |
Condition
Condition
Healthy Adult Volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine whether peripheral veins dilate as a result of a blood flow-dependent vasodilation response (Flow mediated dilatation, FMD), induced by performing short-term blood expulsion using a blood pressure cuff placed on the upper limb.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peripheral Venous Diameter
Key secondary outcomes
Perfusion index, body temperature, blood pressure
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
short-term blood occlusion and release in the upper arm
Interventions/Control_2
Upper limb held at rest
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
Healthy Adult Volunteers with ASA (American Society of Anesthesia) PS (Physical Status) 1-2
Key exclusion criteria
Under 20 years of age
ASA PS 3 or higher
Currently undergoing treatment for upper limb skin diseases
History of wounds on the upper limbs
History of cardiovascular diseases
Taking vasoactive drugs such as antihypertensive agents
Being treated for severe diabetes
Cases where consent was not obtained"
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kinoshita |
| Middle name | |
| Last name | Michiko |
Organization
Tokushima University Hospital
Division name
Department of Anesthesiology
Zip code
770-8503
Address
2-50-1 Kuramoto-cho, Tokushima
TEL
088-633-7181
michiko-kinoshita@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kinoshita |
| Middle name | |
| Last name | Michiko |
Organization
Tokushima University Hospital
Division name
Department of Anesthesiology
Zip code
770-8503
Address
2-50-1 Kuramoto-cho, Tokushima
TEL
088-633-7181
Homepage URL
michiko-kinoshita@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Non profit foundation Kojinkai
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1, Kuramoto-cho, Tokushima
Tel
088-633-8512
first-ec@tokushima-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://journals.sagepub.com/doi/abs/10.1177/11297298241273642
Number of participants that the trial has enrolled
15
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
| 2023 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Management information
Registered date
| 2023 | Year | 07 | Month | 20 | Day |
Last modified on
| 2024 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058957
