UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032095 |
|---|---|
| Receipt number | 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 | 2021/04/06 10:50:07 |
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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
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
t-inoue@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Graduate school of Medicine Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036619
