UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032095
Receipt No. R000036619
Scientific Title Effects of venodilation technique for peripheral intravenous cannulation in elderly adult(the effect of thermal stimulus)
Date of disclosure of the study information 2018/04/04
Last modified on 2018/10/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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
Email 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
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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 16 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
2018 Year 04 Month 04 Day
Last modified on
2018 Year 10 Month 04 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.