UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051043 |
|---|---|
| Receipt number | R000058195 |
| Scientific Title | Effectiveness of heat application using a hot pack on venous dilatation at the site of a peripheral intravenous catheterization in hospitalized older patients: a quasi-experimental study |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2023/05/12 09:55:28 |
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Basic information
Public title
Effectiveness of heat application using a hot pack on venous dilatation at the site of a peripheral intravenous catheterization in hospitalized older patients: a quasi-experimental study
Acronym
Effectiveness of heat application using a hot pack on venous dilatation in hospitalized older patients
Scientific Title
Effectiveness of heat application using a hot pack on venous dilatation at the site of a peripheral intravenous catheterization in hospitalized older patients: a quasi-experimental study
Scientific Title:Acronym
Effectiveness of heat application using a hot pack on venous dilatation in hospitalized older patients
Region
| Japan |
Condition
Condition
Older patients
Classification by specialty
| Medicine in general | Surgery in general | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the venous dilatation effect of applying a tourniquet after forearm heat application with a hot pack to that of applying a tourniquet alone in hospitalized older patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Venous diameter
Key secondary outcomes
Venous depth
Venous assessment scale
Skin surface temperature
Medical records
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Applying a tourniquet for 30 seconds
Interventions/Control_2
Applying a hot pack for 7 minutes
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients aged >65 years
Key exclusion criteria
Patients who cannot fully understand the purpose of this study
Patients who cannot complain of thermal sensation
Patients who have difficulty intervening in their forearm due to symptoms or treatment
Patients with peripheral arterial disease
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Rika |
| Middle name | |
| Last name | Yano |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Department of Fundamental Nursing
Zip code
060-0812
Address
N12-W5, Kitaku, Sapporo, Hokkaido
TEL
011-706-3323
r-yano@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Rika |
| Middle name | |
| Last name | Yano |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Department of Fundamental Nursing
Zip code
060-0812
Address
N12-W5, Kitaku, Sapporo, Hokkaido
TEL
011-706-3323
Homepage URL
r-yano@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Faculty of Health Sciences, Hokkaido University
Address
Kita 12, Nishi 5, Kita-ku Sapporo, Hokkaido, Japan
Tel
011-706-3323
r-yano@med.hokudai.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
| 2023 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 12 | Day |
Last modified on
| 2023 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058195
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
