UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Qualification of EEG obtained from EEG interface device during general anesthesia
Title of the study (Brief title)	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	Satoshi Hagihria
Organization	Osaka University Graduate School of Medicine
Division name	Department of Anesthesiology and Intensive Care Medicine
Address	2-2 Yamadaoka, Suita City
TEL	06(6879)3133
Email	hagihira@anes.med.osaka-u.ac.jp

Public contact
Name of contact person	Satoshi Hagihira
Organization	Osaka University Graduate School of Medicine
Division name	Department of Anesthesiology and Intensive Care Medicine
Address	2-2 Yamadaoka, Suita City
TEL	06(6879)3133
Homepage URL
Email	hagihira@anes.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017314