UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prewarming prevents perioperative hypothermia
Title of the study (Brief title)	Prewarming prevents perioperative hypothermia
Region	Japan

Condition
Condition	Patients undergoing general anesthesia for elective surgery
Classification by specialty	Urology Anesthesiology Operative medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate effects of thirty minutes prewarming on intraoperative hypothermia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Reduce decreases of body temperature in an hour at induction of general anesthesia
Key secondary outcomes	Prevent a hypothermia

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	thirty minutes prewarming with BairPaws
Interventions/Control_2	Wear BairPaws, but no warming
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Elective Urology surgery on general anesthesia, supine or lithotomy position
Key exclusion criteria	Physical status of American society of anesthesiologist class 3 and over
Target sample size	90

Research contact person
Name of lead principal investigator	Hisashi Fukushima
Organization	National Hospital Organization Mito Medical Center
Division name	Anesthesiology
Address	Ibarakiken higashiibarakigun ibarakimachi sakuranosato 280
TEL	029-240-7711
Email	hisashi28@aol.com

Public contact
Name of contact person	Hisashi Fukushima
Organization	National Hospital Organization Mito Medical Center
Division name	Anesthesiology
Address	Ibarakiken higashiibarakigun ibarakimachi sakuranosato 280
TEL	029-240-7711
Homepage URL
Email	hisashi28@aol.com

Sponsor
Institute	National Hospital Organization
Institute
Department

Funding Source
Organization	National Hospital Organization
Organization
Division
Category of Funding Organization
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	2015 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 09 Day
Anticipated trial start date	2015 Year 04 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	2015 Year 03 Month 23 Day
Last modified on	2016 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019597