Aspect Medical Systems, Inc. (Aspect) has planned to complete the COST_2 Study for Bispectral Index Monitor by June 2010. The aim of the study is to determine if the use of a device called the BIS monitor in addition to the Richmond Agitation Sedation Scale will give better assessment of a subject's level of sedation. The study is currently recruiting participants in US.
This randomized, open label, parallel assignment, safety/efficacy study will approximately enroll 350 participants. The study Principal Investigator is DaiWai M Olson, PhD RN Duke University.
The BIS monitor is a sensor strip taped to the forehead and attached to a device that reads electrical activity from the brain. It is approved by the US Food and Drug Administration (FDA) for monitoring patients under sedation.
The official title of the study is “Combining Objective and Subjective Sedation Assessment Tools -Second Study”.