209
Participants
Start Date
July 2, 2021
Primary Completion Date
October 12, 2022
Study Completion Date
October 12, 2022
BIS Complete Monitoring System
The BIS™ complete monitoring system is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on the acquisition and processing of EEG signals. The BIS™ complete system processes raw EEG signals to produce a single number, called the BIS™ index, which correlates with the patient's level of hypnosis. A sensor placed on the patient's head transmits EEG signals to the BISx™ unit. The BIS™ unit filters and digitizes the signal, analyzes it for the artifact, and processes it using digital signal processing techniques to derive processed EEG parameters to a single Bispectral Index (BIS™), and finally sends the processed data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal that the BIS™ algorithm can utilize to derive BIS Index.
University of Pittsburgh Medical Center, Children's Hospital, Pittsburgh
Atrium Health Wake Forest Baptist, Winston-Salem
Duke University Medical Center, Durham
University of Minnesota, Minneapolis
Lurie Children's Hospital of Chicago, Chicago
University of Texas Southwestern Medical Center, Dallas
Children's Hospital Colorado, Aurora
Rutgers University, Newark
Lead Sponsor
Medtronic - MITG
INDUSTRY