UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016447 |
|---|---|
| Receipt number | 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 | 2023/02/10 11:47:48 |
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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
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
kanzaki0812@gmail.com
Sponsor or person
Institute
Hiroshima university hospital
Institute
Department
Personal name
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
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
Terminated
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
| 2023 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017633
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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