UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Forced-Air Warming by an Underbody-Type Blanket: a Propensity Score-Matched Analysis
Title of the study (Brief title)	Effects of Forced-Air Warming by an Underbody-Type Blanket: a Propensity Score-Matched Analysis
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study was to determine the effect of forced-air warming by the underbody-type blanket on anesthetized patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Body temperature at the start and end of surgery in the anesthetized patients
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	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Underbody-type blanket for forced-air warming
Interventions/Control_2	Conventional blanket for forced-air 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

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All patients who underwent surgery between April 2014 and November 2015
Key exclusion criteria	None
Target sample size	8032

Research contact person
Name of lead principal investigator	Shigekazu Sugino
Organization	Tohoku University School of Medicine
Division name	Department of Anesthesiology and Perioperative Medicine
Address	2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL	0227177321
Email	shigekazu.sugino.d3@tohoku.ac.jp

Public contact
Name of contact person	Shigekazu Sugino
Organization	Tohoku University School of Medicine
Division name	Department of Anesthesiology and Perioperative Medicine
Address	2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL	0227177321
Homepage URL
Email	shigekazu.sugino.d3@tohoku.ac.jp

Sponsor
Institute	Tohoku University School of Medicine, Department of Anesthesiology and Perioperative 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	Self funding
Organization
Division
Category of Funding Organization	Self funding
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	東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 27 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 03 Month 17 Day
Anticipated trial start date	2016 Year 03 Month 18 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 06 Month 27 Day
Last modified on	2016 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026400