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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, General
• Intervention / Treatment: Device: BIS device

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 Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study will include maximum 100 screened adult patients and no more than 60 valid cases who will undergo elective surgery under general anesthesia and who will comply with the inclusions criteria

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with recording from 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	Device: BIS device; Recording data from BIS device from patients who undergo elective surgery under general anesthesia

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Aeyal Raz, MD; Ph.D, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Actual): August 11, 2020
• Study Completion (Actual): August 11, 2020

Study Registration Dates

• First Submitted: May 31, 2018
• First Submitted That Met QC Criteria: May 31, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 25, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Anesthesia; Bispectral index (BIS™)
• Other Study ID Numbers: MDT18003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes