Clinical trials: Bispectral Index
Brain Monitor, Anaesthesia
Evaluation of the BRAINDEX Brain Monitor in Cardiac Surgery, Interventional Comparative Study
The main objective of this study is to show the concordance of the SctO2 values of the ARGOS platform with the standard SctO2 values (comparative study with platform INVOS, Medtronic).
- Trial name
- ARGOS Platform (NCT06594198)
- Testing
- Cerebral monitor
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Braindex
Anesthesia
The Influence of Age on EEG Signals and Consciousness During Anesthesia
This is a prospective, multi-center, non-invasive, interventional, data collection study to improve the current BIS algorithm in the elderly adult population.
- Trial name
- TIARA (NCT04765046)
- Testing
- Bispectral (BIS™) Complete Monitoring System
- Where
- 2 sites in Israel, Netherlands
- Volunteers
- 90 people
- Sponsor
- Medtronic - MITG
Anesthesia
Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients
The purpose of this study is to investigate the relationship between BIS™ values including EEG profile and anesthetic agents in the pediatric population
- Trial name
- BTIGER (NCT04810481)
- Testing
- BIS Complete Monitoring System
- Where
- 8 sites in United States
- Volunteers
- 209 people
- Sponsor
- Medtronic - MITG
Anesthesia
Bispectral Index and Levels of Sedation With Propofol With/Without Remifentanil in Healthy Volunteers (SONORA)
The purpose of this study is investigate the relationship between BIS™ and propofol with/without remifentanil across a wide range of hypnotic states.
- Trial name
- SONORA (NCT04466384)
- Testing
- BIS
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Anesthesia, General
Characterization of Artifacts in the BIS™ EEG Signals in General Anesthesia Patients in Operating Room
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…
- Trial name
- RAMBAM (NCT03553953)
- Testing
- BIS device
- Where
- Israel
- Volunteers
- 98 people
- Sponsor
- Medtronic - MITG
Pain
ADVANCE: Assessment for Defining Variability in Anesthesia Through Novel Clinical EEG
The present study is designed to compare prospectively whether sBIS, sEMG, or CVI variability (brain monitoring) can be used to predict unwanted intraoperative responses (high blood pressure, fast heart rate, tearing, etc.) to…
- Trial name
- CVI (NCT00689130)
- Where
- 4 sites in United States, Spain
- Volunteers
- 120 people
- Sponsor
- Medtronic - MITG
Anesthesia
Evaluation of Bispectral Index (BIS™) and Levels of Sedation With Common Inhalational Anesthetics in Healthy Volunteers (OLIVER)
To investigate the relationship between BIS™ and inhaled anesthetics across a wide range of anesthetic concentration and hypnotic states, and to provide evidence to support BIS™ performance in use with Isoflurane, Sevoflurane and…
- Trial name
- OLIVER (NCT04602546)
- Testing
- BIS Complete Monitoring System
- Where
- 3 sites in United States
- Volunteers
- 211 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG