UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057327 |
|---|---|
| Receipt number | R000061325 |
| Scientific Title | Comparison of Venous Distension, Palpable Distension, and Pain Intensity in the Lower Extremities at Different Ejection Pressures Using a Scaled Tourniquet. |
| Date of disclosure of the study information | 2025/03/19 |
| Last modified on | 2025/03/18 14:15:13 |
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Basic information
Public title
Comparison of Venous Distension, Palpable Distension, and Pain Intensity in the Lower Extremities at Different Ejection Pressures Using a Scaled Tourniquet.
Acronym
Changes in the Veins of the Lower Extremities due to different ejection pressures.
Scientific Title
Comparison of Venous Distension, Palpable Distension, and Pain Intensity in the Lower Extremities at Different Ejection Pressures Using a Scaled Tourniquet.
Scientific Title:Acronym
Changes in the Veins of the Lower Extremities due to different ejection pressures.
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarifying the Degrees of Venous Distension, Palpable Distension, and Pain in the Lower Extremities at Different Ejection Pressures Using a Scaled Tourniquet.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Venous Distension
Palpable Distension
Pain Intensity
Key secondary outcomes
Basic Data of the Subjects:
a. Age
b. Gender
c. Blood Pressure: Measured at the Ankle
d. Circumference of the Limb Constriction Site (5cm proximal to the ankle)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Venous constriction was performed using a scaled tourniquet, set to two markers above the baseline position.
Interventions/Control_2
Venous constriction was performed using a scaled tourniquet, set to three markers above the baseline position.
Interventions/Control_3
Venous constriction was performed using a scaled tourniquet, set to four markers above the baseline position.
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants who met the following pre-screening criteria and provided consent were included in the study:
No underlying diseases (no current need for treatment for any disease)
No history of wounds or surgery on the lower limbs
No limitations in the mobility of the lower limbs
No history of latex allergy
Key exclusion criteria
Those who do not meet the selection criteria
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Ryuta |
| Middle name | |
| Last name | Ibe |
Organization
Tokyo Healthcare University
Division name
Advanced Practice Nursing Course, Graduate School of Nursing Science, Higashigaoka.
Zip code
152-8558
Address
2-5-1 Higashigaoka, Meguro, Tokyo
TEL
03-5779-5031
kg023005@thcu.ac.jp
Public contact
Name of contact person
| 1st name | Ryuta |
| Middle name | |
| Last name | Ibe |
Organization
Tokyo Healthcare University
Division name
Advanced Practice Nursing Course, Graduate School of Nursing Science, Higashigaoka.
Zip code
152-8558
Address
2-5-1 Higashigaoka, Meguro, Tokyo
TEL
03-5779-5031
Homepage URL
kg023005@thcu.ac.jp
Sponsor or person
Institute
Tokyo Healthcare University
Institute
Department
Personal name
Ibe Ryuta
Funding Source
Organization
Tokyo Healthcare University
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
The Ethical Review Board for Human-related Research, Tokyo Healthcare University.
Address
4-1-17 Higashigotanda, Shinagawa, Tokyo
Tel
03-5721-7655
rinri@thcu.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
| 2025 | Year | 03 | Month | 19 | 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
30
Results
3 marks (109.6 +/- 13.0 mmHg) was suggested as optimal for lower limb venipuncture.
Results date posted
| 2025 | Year | 03 | Month | 18 | Day |
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
| 2024 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 18 | Day |
Last modified on
| 2025 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061325
