UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021103 |
|---|---|
| Receipt number | R000024347 |
| Scientific Title | Effects of venodilation techiniques for peripheral intravenous cannulation(the effect of execise) |
| Date of disclosure of the study information | 2016/02/19 |
| Last modified on | 2017/03/22 20:53:24 |
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Basic information
Public title
Effects of venodilation techiniques for peripheral intravenous cannulation(the effect of execise)
Acronym
Effects of venodilation techiniques using execise
Scientific Title
Effects of venodilation techiniques for peripheral intravenous cannulation(the effect of execise)
Scientific Title:Acronym
Effects of venodilation techiniques using execise
Region
| Japan |
Condition
Condition
health general people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of venodilation techiniques.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
vein area 30 seconds after intervention
Key secondary outcomes
vein diameter 30 seconds after intervention
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
10
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A)application of a tourniquet for 30 seconds
B)application of a tourniquet with lower limb elevation for 30 seconds
C)application of a tourniquet with clenching for 30 seconds
D)application of a tourniquet with lowerlimb elevation and clenching for 30 seconds
All participants receive all intervention(A-D).
We perform the intervention(A-D) in random order.
We expalin the ordes as follow(Interventions/Control_1-10).
In addition, we expain the reset of order inthe section of "other related information"
A-B-C-D
Interventions/Control_2
A-B-D-C
Interventions/Control_3
A-C-B-D
Interventions/Control_4
A-C-D-B
Interventions/Control_5
A-D-B-C
Interventions/Control_6
A-D-C-B
Interventions/Control_7
B-A-C-D
Interventions/Control_8
B-A-D-C
Interventions/Control_9
B-C-A-D
Interventions/Control_10
B-C-D-A
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy adult
Key exclusion criteria
1)receiving treatment for skin disease
2)a wound or eczema at the target site
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoko Inoue |
Organization
Graduate school of Medicine Osaka University
Division name
Division of health science
Zip code
Address
1-7 Yamadaoka, Suita, Osaka
TEL
06-6879-2526
t-inoue@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Inoue |
Organization
Graduate school of Medicine Osaka University
Division name
Division of health science
Zip code
Address
1-7 Yamadaoka, Suita, Osaka
TEL
06-6879-2526
Homepage URL
t-inoue@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Graduate school of Medicine Osaka University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for Promotion of Science(JSPS)
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | 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
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
in intervention section, although we explain number of group was 10, in fact the number is 24. We cannot write it with the system limitations.
In this study, we have 4 intervention(s)(A, B, C, D).
The participants receive all intervention(s) in random order.
The number of order is 24.
We perform the interventions in random order.
The rest of order(group 11-24) is as follow,
B-D-A-C
B-D-C-A
C-A-B-D
C-A-D-B
C-B-A-D
C-B-D-A
C-D-A-B
C-D-B-A
D-A-B-C
D-A-C-B
D-B-A-C
D-B-C-A
D-C-A-B
D-C-B-A
Management information
Registered date
| 2016 | Year | 02 | Month | 19 | Day |
Last modified on
| 2017 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024347
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
