Feasibility of Automated Propofol Sedation for Transcatheter Aortic Valve Implantation: A Pilot Study.

BACKGROUND: Recently, several trials have shown that closed-loop sedation is feasible. No study has used automated sedation in extremely frail patients, such as those scheduled for transcatheter aortic valve implantation (TAVI). We developed and tested a novel automated sedation system for this kind of population and surgery. The system integrates a decision support system that detects respiratory and hemodynamic events via smart alarms, which provide pertinent/related clinical suggestions and treatment options. The main objective was the feasibility of closed-loop sedation, defined as successful automated sedation without manual override. Secondary qualitative observations were clinical and controller performance. METHODS: Twenty patients scheduled for elective TAVI were enrolled. Sedation was administered via a closed-loop delivery system designed for propofol. The clinical performance of sedation was the efficacy to maintain a bispectral index (BIS) of 65. To evaluate the sedation performance, BIS values were stratified into 4 categories: excellent, very good, good, and inadequate sedation control, defined as BIS values within 10%, ranging from 11% to 20%, ranging from 21% to 30%, or >30% from the target value, respectively. The controller performance was calculated using Varvel parameters. Critical respiratory and hemodynamic events were documented. The former was defined as peripheral oxygen saturation

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