UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014890 |
|---|---|
| Receipt number | R000017314 |
| Scientific Title | Qualification of EEG obtained from EEG interface device during general anesthesia |
| Date of disclosure of the study information | 2014/08/20 |
| Last modified on | 2016/12/29 16:11:50 |
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Basic information
Public title
Qualification of EEG obtained from EEG interface device during general anesthesia
Acronym
Exploring a low-cost EEG monitor
Scientific Title
Qualification of EEG obtained from EEG interface device during general anesthesia
Scientific Title:Acronym
Exploring a low-cost EEG monitor
Region
| Japan |
Condition
Condition
patients who were scheduled surgery under general anesthesia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the quality of EEG obtained from the Brain Computer Interface (BCI) device with that obtained from an EEG monitor during general anesthesia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
test the robustness of EEGs obtained from the devices against the electric noise 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with ASA-PS I or II who were
obtained written informed consent
Key exclusion criteria
(1) patients who had brain disease such as brain tumor, brain infarction, epilepsy etc.
(2) patients who recieved drugs before surgery that might have influence on EEG.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Hagihria |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
Address
2-2 Yamadaoka, Suita City
TEL
06(6879)3133
hagihira@anes.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Hagihira |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
Address
2-2 Yamadaoka, Suita City
TEL
06(6879)3133
Homepage URL
hagihira@anes.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
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
大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 20 | 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
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
In this research, we compares the quality of EEG simultaneously obtained from two devices.
Management information
Registered date
| 2014 | Year | 08 | Month | 19 | Day |
Last modified on
| 2016 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017314
