Characterization of Artifacts in the BIS™ EEG Signals in General Anesthesia Patients in Operating Room

Study Overview
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Brief Summary
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This is an observational non-invasive study which aims to collect data from patients under general anesthesia in the operating room; this data will then be used for characterization and detection of artifacts that affect the EEG signal.

Detailed Description
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This observational, non-invasive study will be performed in order to identify the effects of physiological and environmental artifacts on the EEG raw data collected by the BIS™. This study will include 100 screened subjects (not more than 60 valid cases) and will take place in the Department of Anesthesiology at Rambam Health Care Campus. During the study, raw data from the BIS™ will be recorded simultaneously with EMG, EOG and ECG in order to diagnose their effects on the EEG signals as recorded by the BIS™. The raw data will be considered as the main parameters of the study. Additionally, a study coordinator will stay in the operating room during the surgery and will indicate the following parameters - Medical treatment (drug, dosage and time) Changes in hypnotic state (state, time) Any activity that may affect the EEG signals (i.e. electrical and mechanical artifacts from medical devices) Any activity that deviates from the clinical procedure Any adverse events or unusual outcomes From the list above, parameters a, c and d will also be considered as main parameters and parameters and parameters d and e will be considered as safety parameters. If applicable, BIS™ will be recorded after the surgery, at the PACU, for part of time the subject will be at the PACU or until the subject will be released from the department. The study coordinator/investigator will perform POD assessment at that time. The subject will be considered as valid case even if the data from the recovery room is missing. Demographic details and medical history will be copied by the study coordinator from the subjects' medical records.

Official Title
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Characterization of Artifacts in the BIS™ EEG Signals in General Anesthesia Patients in Operating Room

Conditions
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Anesthesia, General

Intervention / Treatment
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* Device: BIS device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and Women Age >18 Ability and willingness to participate in the study and sign informed consent form Patients that will undergo elective surgery under general anesthesia. Exclusion Criteria: Pregnant women Disability or unwillingness to undergo EEG/EMG/ECG measurement Subjects with known or suspected sensitivity to adhesive bandage Subjects who have sustained CVA or severe head trauma in the last 10 years. Subjects with known or suspected electroencephalograph abnormality (e.g. epilepsy or scarring) soldiers prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with recording from BIS device<br>One hundred screened adult patients and no more than 60 valid cases who undergo elective surgery under general anesthesia with recording from the BIS device at the same time and comply with the inclusions criteria | Device: BIS device<br>* Recording data from BIS device from patients who undergo elective surgery under general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recording of data that potentially indicates artifacts | The primary objective of the study is to measure and report: EMG, EOG and ECG data, each using the respective standard medical device for each parameter; EEG data using the BIS™ device; Environmental events occurring during the same time period (e.g. electrical artifacts) | 24 hours or less | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of demographic and clinical parameters on EEG | Generating a database of demographic and clinical data (e.g. level of consciousness, age, gender, BMI, anesthetic agents being used during the study, ASA level, etc.) in order to measure its effect on the EEG data collected with the BIS™. | week or less | 
| Immediate post-operative data | collect post-operative data in order to assess correlation between EEG data collected with the BIS™ and immediate post-operative delirium (POD) | week or less | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Bispectral index (BIS™)