UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025999 |
|---|---|
| Receipt number | R000027927 |
| Scientific Title | Study of changes in the peripheral temperature due to different usage of heat absorption fider |
| Date of disclosure of the study information | 2017/02/28 |
| Last modified on | 2017/02/04 01:43:40 |
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Basic information
Public title
Study of changes in the peripheral temperature due to different usage of heat absorption fider
Acronym
Study of changes in the peripheral temperature due to different usage of heat absorption fider
Scientific Title
Study of changes in the peripheral temperature due to different usage of heat absorption fider
Scientific Title:Acronym
Study of changes in the peripheral temperature due to different usage of heat absorption fider
Region
| Japan |
Condition
Condition
Is a nurse of the 20-40 years old to work In our House ICU; is a person without the damage and the peripheral circulatory disease to lower limbs
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
I confirm presence of the difference in peripheral temperature change by measuring peripheral surface temperature and deep part temperature by different usage of the moisture absorption fever fiber.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
For a patient needing the prevention of the peripheral bloodstream disorder and early rewarming, I can give effective support.
Key secondary outcomes
It inflects as the document which plans unification if there is a difference.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
I bind the right leg of the target person with the thing which cut moisture absorption fever fiber to one meter square in a spiral and I hang it to the left leg and use it.
I use both lower limbs to the toe tip so that there is not an exposure side.
Interventions/Control_2
I put the probe of the deep part temperature monitor on the back of the thumb of the lower limbs of right and left of the target person and perform thermometry at the tip temperature every ten minutes after use since before having used moisture absorption fever fiber and photograph thermography.
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
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Is a nurse of the 20-40 years old to work in our House ICU; is a person without the damage and the peripheral circulatory disease to lower limbs. The person who is not poor physical condition on a study enforcement day.
The person that it was obtained its consent after enough understanding after having received enough explanation on study entry.
Key exclusion criteria
A pregnant person.
The person whom a study person in charge judged to be inappropriate as a study subject.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | seiko fujino |
Organization
yamaguuchi university hosiptal
Division name
ICU
Zip code
Address
1-1-1 Minamikogushi Ube-shi Yamaguchi-ken
TEL
0836-22-2111
seikof@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | seiko fujino |
Organization
yamaguuchi university hosiptal
Division name
ICU
Zip code
Address
1-1-1 Minamikogushi Ube-shi Yamaguchi-ken
TEL
0836-22-2653
Homepage URL
seikof@yamaguchi-u.ac.jp
Sponsor or person
Institute
yamaguuchi university hosptal
Institute
Department
Personal name
Funding Source
Organization
yamaguuchi university hosptal
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 02 | Month | 28 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | 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
| 2017 | Year | 02 | Month | 04 | Day |
Last modified on
| 2017 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027927
| Research Plan | |
|---|---|
| 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 |
