UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of changes in the peripheral temperature due to different usage of heat absorption fider
Title of the study (Brief title)	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	seiko fujino
Organization	yamaguuchi university hosiptal
Division name	ICU
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	seiko fujino
Organization	yamaguuchi university hosiptal
Division name	ICU
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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