UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021106 |
|---|---|
| Receipt number | R000024353 |
| Scientific Title | Effects of venodilation technique for peripheral intravenous cannulation(the effect of thermal stimulus) |
| Date of disclosure of the study information | 2016/02/19 |
| Last modified on | 2017/03/22 20:54:06 |
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Basic information
Public title
Effects of venodilation technique for peripheral intravenous cannulation(the effect of thermal stimulus)
Acronym
Effect of venodilation techinique using thermal stimulus
Scientific Title
Effects of venodilation technique for peripheral intravenous cannulation(the effect of thermal stimulus)
Scientific Title:Acronym
Effect of venodilation techinique using thermal stimulus
Region
| Japan |
Condition
Condition
health general people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of venodilation technique using thermal stimulus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
vein area after intervention (application of heat stimulus for 15 minutes and tourniquet for 30 seconds)
Key secondary outcomes
vein shortest and longest diameter after intervention (application of heat stimulus for 15 minutes and tourniquet for 30 seconds)
skin temperature on intervention side after intervention
body temperature, systolic blood pressure and diastolic blood pressure on non-intervention side arm after the intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
application of heat pack for 15 minutes and tourniquet for 30 seconds
Interventions/Control_2
application of sham treatment and tourniquet tourniquet for 30 seconds
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
| 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
70
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
Graduate school of medicine Osaka University
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-inou@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
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=R000024353
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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