NCT03553953

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 98 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia, General

Interventions

Type	Name	Description
DEVICE	BIS device	Recording data from BIS device from patients who undergo elective surgery under general anesthesia

Timeline

• Start date: 2018-08-15
• Primary completion: 2020-08-11
• Completion: 2020-08-11
• First posted: 2018-06-12
• Last updated: 2020-09-29

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated device study