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

Completed

• Conditions: Anesthesia, General
• Interventions: Device: BIS device

• Registration Number: NCT03553953
• Lead Sponsor: Medtronic - MITG

Brief Summary

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

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 -

1. Medical treatment (drug, dosage and time)

2. Changes in hypnotic state (state, time)

3. Any activity that may affect the EEG signals (i.e. electrical and mechanical artifacts from medical devices)

4. Any activity that deviates from the clinical procedure

5. 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.

Study Timeline

• Study First Submitted: 2018-05-31
• Study First Submitted QC: 2018-05-31
• Study First Posted: 2018-06-12
• Study Start: 2018-08-15
• Primary Completion: 2020-08-11
• Study Completion: 2020-08-11
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-25
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with recording from BIS device	BIS device	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

Primary Outcome Measures

Name	Time	Method
Recording of data that potentially indicates artifacts	24 hours or less	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)

Secondary Outcome Measures

Name	Time	Method
The effect of demographic and clinical parameters on EEG	week or less	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™.
Immediate post-operative data	week or less	collect post-operative data in order to assess correlation between EEG data collected with the BIS™ and immediate post-operative delirium (POD)

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel