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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017108
Receipt No. R000019845
Scientific Title Study of Heat receipts and disbursements during general anesthesia by heat flow meter
Date of disclosure of the study information 2015/05/01
Last modified on 2018/10/17

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Basic information
Public title Study of Heat receipts and disbursements during general anesthesia by heat flow meter
Acronym Study of Heat receipts and disbursements during general anesthesia by heat flow meter
Scientific Title Study of Heat receipts and disbursements during general anesthesia by heat flow meter
Scientific Title:Acronym Study of Heat receipts and disbursements during general anesthesia by heat flow meter
Region
Japan

Condition
Condition patient for general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Using a heat flow meter, consider the temperature and heat teller during general anesthesia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body temperature and heat flow value of body surface during general anesthesia
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 Patients undergoing general anesthesia
Key exclusion criteria Patients who did not consent to the person or guardian
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mikito Kawamata
Organization Shinshu University school of medicine
Division name The department of anesthesiology and resuscitology
Zip code
Address 3-1-1 Asahi Matsumoto city Nagano
TEL 0262-37-2670
Email masui@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toru Murakami
Organization Shinshu University school of medicine
Division name The department of anesthesiology and resuscitology
Zip code
Address 3-1-1 Asahi Matsumoto city Nagano
TEL 0262-37-2670
Homepage URL
Email torum@shinshu-u.ac.jp

Sponsor
Institute Shinshu University school of medicine
Institute
Department

Funding Source
Organization Shinshu University school of medicine
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 05 Month 01 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
2015 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information After entering operating room, a thermal flow sensor is stuck to patient's skin by using a tape before anesthetic introduction. the data is taken in software for analyses every regular interval .When measuring the indirect calorimetry, We use Carescape bedside monitor which metabolism monitor has been built (GE healthcare) and metabolic measurement module. Anesthesia and a monitoring are performed as usual.

Management information
Registered date
2015 Year 04 Month 11 Day
Last modified on
2018 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019845

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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