CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
Bispectral (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/NCT04765046
NCT04765046N/ACompleted

The Influence of Age on EEG Signals and Consciousness During Anesthesia (TIARA)

Medtronic - MITG·interventional·Posted Feb 21, 2021·Updated Jul 3, 2024

In Brief

A clinical study evaluating Bispectral (BIS™) Complete Monitoring System for Anesthesia. Completed, enrolled 90 participants across 2 sites in 2 countries.

Detailed Summary

This is a prospective, multi-center, non-invasive, interventional, data collection study to improve the current BIS algorithm in the elderly adult population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia
CountriesIsrael, Netherlands
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 21, 2021
Enrollment StartAug 18, 2021
Primary CompletionApr 3, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.4 years ago

Interventions

Bispectral (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 technology converts raw EEG data acquired from the frontal cortex into a single number to measure the level of consciousness, called the BIS index. A bilateral sensor is to be placed on the patient's forehead to collect the EEG signals and transmit them back to the system.