CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 209 enrolled
Drug / intervention
BIS Complete Monitoring Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04810481
NCT04810481N/ACompleted

Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients Undergoing Sevoflurane Anesthesia (BTIGER)

Medtronic - MITG·interventional·Posted Mar 23, 2021·Updated Apr 18, 2023

In Brief

A clinical study evaluating BIS Complete Monitoring System for Anesthesia. Completed, enrolled 209 participants across 8 sites.

Detailed Summary

The purpose of this study is to investigate the relationship between BIS™ values including EEG profile and anesthetic agents in the pediatric population

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 23, 2021
Enrollment StartJul 2, 2021
Primary CompletionOct 12, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.3 years ago

Interventions

BIS Complete Monitoring Systemdevice

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.