UMIN-CTR Clinical Trial

Basic information
Public title	Effects of venodilation technique for peripheral intravenous cannulation in elderly adult(the effect of thermal stimulus)
Acronym	Effect of venodilation techinique using thermal stimulus in elderuly adult
Scientific Title	Effects of venodilation technique for peripheral intravenous cannulation in elderly adult(the effect of thermal stimulus)
Scientific Title:Acronym	Effect of venodilation techinique using thermal stimulus in elderuly adult
Region	Japan

Condition
Condition	healthy adult
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of venodilation technique using thermal stimulus in eldely adult
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	vein cross-sectional area after intervention (application of heat stimulus and tourniquet)
Key secondary outcomes	vein shortest and longest diameter after intervention (application of heat stimulus and tourniquet) vein visibility and palpability skin temperature on intervention side after intervention body temperature, systolic blood pressure and diastolic blood pressure

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	6
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	A)application of a tourniquet B)application of a heat pack and tourniquet C)application of a heat warmer and tourniquet All participants receive all intervention(A-C). We perform the intervention(A-C) in random order. A-B-C
Interventions/Control_2	A-C-B
Interventions/Control_3	B-C-A
Interventions/Control_4	B-C-A
Interventions/Control_5	C-A-B
Interventions/Control_6	C-B-A
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	Not applicable
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	35

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	565-0871
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	1st name Tomoko Middle name Last name Inoue
Organization	Graduate school of Medicine Osaka University
Division name	Division of health science
Zip code	565-0871
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	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University Hospital
Address	1-7 Yamadaoka, Suita, Osaka
Tel	06-6210-8296
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	2018 Year 04 Month 04 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	Suspended
Date of protocol fixation	2018 Year 03 Month 16 Day
Date of IRB	2018 Year 03 Month 16 Day
Anticipated trial start date	2018 Year 03 Month 16 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 04 Day
Last modified on	2021 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036619