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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014509
Receipt No. R000016786
Scientific Title Investigation of factors in perioperative management of body temperature
Date of disclosure of the study information 2014/07/08
Last modified on 2016/07/08

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Basic information
Public title Investigation of factors in perioperative management of body temperature
Acronym Perioperative management of body temperature
Scientific Title Investigation of factors in perioperative management of body temperature
Scientific Title:Acronym Perioperative management of body temperature
Region
Japan

Condition
Condition Patients undergoing surgery under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the factors in perioperative management of body temperature.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Perioperative core temperature
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 total fresh gas flow delivered by an anesthesia machine into the breathing circuit is 1L/minute.
Interventions/Control_2 total fresh gas flow delivered by an anesthesia machine into the breathing circuit is 3L/minute.
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

Not applicable
Gender Male
Key inclusion criteria Undergoing surgery under general anesthesia
Estimated time of surgery not less than 2 hours
Supine position
Head and neck surgery by department of ophthalmology, otolaryngology, dermatology, plastic and reconstructive surgery, or breast and endocrine surgery
Intubated orotracheally
ASA-PS: I or II
Obtaining documented informed consent from the patient
Key exclusion criteria Operation around thermometer
Administration of hypnotics preoperatively on the day of surgery
Confirmed hyperthyroidism, hypothyroidism, or inflammation (CRP > 1.0mg/dL) except for patients kept within the institutional reference range
Drug in this protocol is unusable for such as allergy
BMI more than 25kg/m^2
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuhiro Ishimura
Organization Kumamoto University Hospital
Division name Surgical Center
Zip code
Address Honjo 1-1-1, Chuo-ku, Kumamoto City, Kumamoto Japan
TEL 096-373-7125
Email tishimura@fc.kuh.kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuhiro Ishimura
Organization Kumamoto University Hospital
Division name Surgical Center
Zip code
Address Honjo 1-1-1, Chuo-ku, Kumamoto City, Kumamoto Japan
TEL 096-373-7125
Homepage URL
Email tishimura@fc.kuh.kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University Hospital
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 07 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 07 Month 08 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 08 Day
Last modified on
2016 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016786

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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