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”.