UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relative clinical heat transfer effectiveness: Forced-air warming(Warm Touch TM) vs. Conductive fabric electric warming(HOT DOG TM).
Title of the study (Brief title)	Relative clinical heat transfer effectiveness: Forced-air warming(Warm Touch TM) vs. Conductive fabric electric warming(HOT DOG TM).
Region	Japan

Condition
Condition	perioperative hypothermia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The comparative clinical heat transfer effectiveness when CFW and FAW are used as systems
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The warming rates of Tympanic temperatures were recorded at 15 minute intervals, starting when the blankets were energized.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Forced-air warming(Warm Touch TM)
Interventions/Control_2	Conductive fabric electric warming(HOT DOG TM)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	19 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients(ASA PS 1-2) undergoing GI or gynecologic surgical procedures lasting more than 2 hours
Key exclusion criteria	Exclusion criteria were: ASA 3 and 4, BMI (kg/m2) <17 and >30, and the use of fluid warming
Target sample size	40

Research contact person
Name of lead principal investigator	Michiaki Yamakage
Organization	Sapporo medical university school of medicine
Division name	Anesthesiology
Address	West16South1,Sapporocity
TEL	011-688-9663
Email	yamakage@sapmed.ac.jp

Public contact
Name of contact person	Haruko Sugai
Organization	Sapporo medical university school of medicine
Division name	Anesthesiology
Address	West16South1,Sapporocity
TEL	011-688-9663
Homepage URL
Email	hayashi.haruko@sapmed.ac.jp

Sponsor
Institute	Sapporo medical university school of medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	the Red Cross Hospital (Asahikawa, Japan)
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	2016 Year 04 Month 04 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 03 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 04 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 03 Day
Last modified on	2016 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000025097