UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026654 |
|---|---|
| Receipt number | R000030608 |
| Scientific Title | Effects of venodilation techniques for peripheral intravenous cannulation (the effect of posture) |
| Date of disclosure of the study information | 2017/03/22 |
| Last modified on | 2020/09/23 10:22:41 |
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Basic information
Public title
Effects of venodilation techniques for peripheral intravenous cannulation (the effect of posture)
Acronym
Effects of venodilation techniques for peripheral intravenous cannulation (the effect of posture)
Scientific Title
Effects of venodilation techniques for peripheral intravenous cannulation (the effect of posture)
Scientific Title:Acronym
Effects of venodilation techniques for peripheral intravenous cannulation (the effect of posture)
Region
| Japan |
Condition
Condition
healthy general people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate difference in venodilation in posture
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vein sectional area after intervention
Key secondary outcomes
Vein shortest diameter, vein longest diameter after intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1)Tourniquet application for 30 second in sitting position.
After the rest more than 5 minutes in supine position,
2)Tourniquet application for 30 second in supine position
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy adult
Key exclusion criteria
1)receiving treatment for skin disease at target site
2)presence of wound or eczema at the target site
Target sample size
77
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Inoue |
Organization
Graduate school of medicine Osaka University
Division name
Division of health science
Zip code
5650871
Address
1-7 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-2526
t-inoue@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Inoue |
Organization
Graduate school of medicine Osaka University
Division name
Division of health science
Zip code
5650871
Address
1-7 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-2526
Homepage URL
t-inoue@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Graduate school od medicine Osaka University
Institute
Department
Personal name
Funding Source
Organization
Ministary of education
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka university hospotal
Address
2-2 Yamadaoka, Suita, Osaka, Japan
Tel
0662108296
rinri@hp-crc.med.osaka-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
| 2017 | Year | 03 | Month | 22 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/31835910/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/31835910/
Number of participants that the trial has enrolled
81
Results
Results of paired t tests demonstrated that the venous cross-sectional area significantly increased in the supine position with tourniquet application compared with the seated position with tourniquet application. Subgroup analysis with two-way repeated measures analysis of variance revealed that the venous cross-sectional area was significantly larger in the supine position than in the seated position despite DPIVC.
Results date posted
| 2020 | Year | 09 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 12 | Month | 13 | Day |
Baseline Characteristics
20-64 years
Participant flow
we recruited 81 participants and included 80 in the analysis.
Adverse events
None
Outcome measures
venous cross-sectional area
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In study design section, although we explained blinding as "open", it is open-but assessor(s) are blinded in fact. We could not describe it with the system limitations.
Management information
Registered date
| 2017 | Year | 03 | Month | 22 | Day |
Last modified on
| 2020 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030608
