Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients

NACompletedINTERVENTIONAL
Enrollment

209

Participants

Timeline

Start Date

July 2, 2021

Primary Completion Date

October 12, 2022

Study Completion Date

October 12, 2022

Conditions
Anesthesia
Interventions
DEVICE

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.

Trial Locations (8)

15224

University of Pittsburgh Medical Center, Children's Hospital, Pittsburgh

27157

Atrium Health Wake Forest Baptist, Winston-Salem

27710

Duke University Medical Center, Durham

55455

University of Minnesota, Minneapolis

60611

Lurie Children's Hospital of Chicago, Chicago

75390

University of Texas Southwestern Medical Center, Dallas

80045

Children's Hospital Colorado, Aurora

07103

Rutgers University, Newark

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medtronic - MITG

INDUSTRY

NCT04810481 - Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients | Biotech Hunter | Biotech Hunter