UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of venodilation techiniques for peripheral intravenous cannulation(the effect of execise)
Title of the study (Brief title)	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	Tomoko Inoue
Organization	Graduate school of Medicine Osaka University
Division name	Division of health science
Address	1-7 Yamadaoka, Suita, Osaka
TEL	06-6879-2526
Email	t-inoue@sahs.med.osaka-u.ac.jp

Public contact
Name of contact person	Tomoko Inoue
Organization	Graduate school of Medicine Osaka University
Division name	Division of health science
Address	1-7 Yamadaoka, Suita, Osaka
TEL	06-6879-2526
Homepage URL
Email	t-inoue@sahs.med.osaka-u.ac.jp

Sponsor
Institute	Graduate school of Medicine Osaka University
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 02 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024347