Computer-assisted personalized sedation (CAPS)

The computer-assisted personalized sedation (CAPS) system is designed to help physician/nurse teams deliver minimal to moderate propofol sedation to patients during endoscopic procedures.  The CAPS system continually monitors and records in real time seven patient parameters: oxygen saturation, respiratory rate, heart rate, blood pressure, end-tidal carbon dioxide, patient responsiveness, and ECG. The system is designed to automatically detect and react to signs of over-sedation by stopping or reducing delivery of propofol, increasing oxygen delivery and automatically instructing patients to take a deep breath. 

In two feasibility studies involving the use of the system in 96 patients undergoing endoscopy, patients remained minimally to moderately sedated throughout the procedure. For the majority of patients, recovery time was less than 1 minute and no serious adverse events occurred.  The nurses assisting in the procedures reported that the system was intuitive and user-friendly, and the built-in dosing limits and automated response algorithms allowed the team to be confident that an appropriate level of sedation was being maintained. 

A subsequent multi-center prospective, randomized, controlled trial compared the safety and effectiveness of the CAPS system to physician-administered sedation regimens involving opioids and benzodiazepines in 1000 patients. Based on these investigations, the system has been submitted to the U.S. FDA for premarket approval under the brand name, SEDASYS™ System, with a decision anticipated in 2008.

www.sedationfacts.org
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