NCT04765046

The Influence of Age on EEG Signals and Consciousness During Anesthesia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a prospective, multi-center, non-invasive, interventional, data collection study to improve the current BIS algorithm in the elderly adult population. The BIS system will be used on-label as approved in the respective study site countries to monitor and non-invasively measure and interpret brain wave activity directly related to the effects of anesthetic agents. The study's purpose is to evaluate the relationship between BIS parameters, age, and depth of anesthesia in patients undergoing surgery under general anesthesia.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DEVICE	Bispectral (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 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.

Timeline

• Start date: 2021-08-18
• Primary completion: 2023-04-03
• Completion: 2023-04-03
• First posted: 2021-02-21
• Last updated: 2024-07-03
• Results posted: 2024-07-03

Locations

2 sites across 2 countries: Israel, Netherlands