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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016447
Receipt No. R000017633
Scientific Title The site of sensor and its accuracy in anesthesia depth monitoring(ENTROPY TM): alternative area to forehead.
Date of disclosure of the study information 2015/02/05
Last modified on 2021/06/16

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Basic information
Public title The site of sensor and its accuracy in anesthesia depth monitoring(ENTROPY TM): alternative area to forehead.
Acronym Alternative monitoring area in anesthesia depth monitoring(ENTROPY TM)
Scientific Title The site of sensor and its accuracy in anesthesia depth monitoring(ENTROPY TM): alternative area to forehead.
Scientific Title:Acronym Alternative monitoring area in anesthesia depth monitoring(ENTROPY TM)
Region
Japan

Condition
Condition Patients scheduled for surgery with general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 EEG electrodes for anesthesia depth monitor are made to place on forehead. However there are the cases with their forehead are not available. In this study, we sill elucidate the alternative area other than forehead for monitoring.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Data (ENTROPY TM's indices) from both authentic(forehead) and other part
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 We will measure data(ENTROPY TM's indices) from both authentic(forehead) and other part(1):front polar
Interventions/Control_2 We will measure data(ENTROPY TM's indices) from both authentic(forehead) and other part(2):frontal
Interventions/Control_3 We will measure data(ENTROPY TM's indices) from both authentic(forehead) and other part(3):central
Interventions/Control_4 We will measure data(ENTROPY TM's indices) from both authentic(forehead) and other part(4):parietal
Interventions/Control_5 We will measure data(ENTROPY TM's indices) from both authentic(forehead) and other part(5):occipital
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 and Female
Key inclusion criteria 1.The patients with >20 years old.
2.The patients agree this research.
3.Estimated operating time with >2 hours.
Key exclusion criteria The patients who are regarded as inappropriate by investigator
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noboru Saeki
Organization Hiroshima university hospital
Division name department of surgery
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima city, Hiroshima, Japan.
TEL 082-257-5267
Email nsaeki@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rieko Kanzaki
Organization Hiroshima university hospital
Division name Anesthesiology and Critical Care
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima city, Hiroshima, Japan.
TEL 082-257-5267
Homepage URL
Email kanzaki0812@gmail.com

Sponsor
Institute Hiroshima university hospital
Institute
Department

Funding Source
Organization Hiroshima university hospital
Organization
Division
Category of Funding Organization
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 02 Month 05 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 Enrolling by invitation
Date of protocol fixation
2015 Year 01 Month 16 Day
Date of IRB
2015 Year 01 Month 16 Day
Anticipated trial start date
2015 Year 02 Month 05 Day
Last follow-up date
2026 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 05 Day
Last modified on
2021 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017633

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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