UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000026654
Receipt No. 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 (Ver. 7)

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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
Email 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
Email t-inoue@sahs.med.osaka-u.ac.jp

Sponsor
Institute Graduate school od medicine Osaka University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030608