UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of hypothermia prevention during surgery by Warming before the general anesthesia introduction in the lung resection
Title of the study (Brief title)	pre-warming
Region	Japan

Condition
Condition	lung resection
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Effect of hypothermia prevention during surgery by Warming before the general anesthesia introduction
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bladder temperature of during surgery
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Warmed more than 10 minutes
Interventions/Control_2	control
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Self-determination Lateral position
Key exclusion criteria	Cognitive disorder
Target sample size	60

Research contact person
Name of lead principal investigator	Kuniyuki Kaneko
Organization	Fukuoka University Hospital
Division name	Operation department
Address	Fukuoka, Fukuoka Prefecture Jonan-ku Nanakuma7-45-1
TEL	092-801-1011
Email	kaneko1114@cis.fukuoka-u.ac.jp

Public contact
Name of contact person	Kuniyuki Kaneko
Organization	Fukuoka University Hospital
Division name	Operation department
Address	Fukuoka, Fukuoka Prefecture Jonan-ku Nanakuma7-45-1
TEL	092-801-1011
Homepage URL
Email	kaneko1114@cis.fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University Hospital
Institute
Department

Funding Source
Organization	Fukuoka University Hospital
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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 21 Day
Anticipated trial start date	2016 Year 06 Month 30 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 12 Month 21 Day
Last modified on	2017 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023421