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

Anesthesia, General Clinical Trial

— RAMBAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553953
• Other study ID #: MDT18003
• Status: Completed
• Start date: August 15, 2018
• Est. completion date: August 11, 2020

Study information

• Verified date: September 2020
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: August 11, 2020
• Est. primary completion date: August 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Device:
• BIS device
Recording data from BIS device from patients who undergo elective surgery under general anesthesia

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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