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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025999
Receipt No. 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

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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
Email 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
Email seikof@yamaguchi-u.ac.jp

Sponsor
Institute yamaguuchi university hosptal
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027927

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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