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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name