Design, implementation, and evaluation of a physiological closed-loop control device for medically-induced coma.

Concerns regarding reliability and safety, as well as uncertainties about what constitutes adequate performance evaluation, have impeded the clinical translation of PCLC devices. We describe an attempt to address these challenges through design, implementation, and evaluation of a PCLC device for delivering medically-induced coma, with the intention to eventually conduct a clinical trial. This device works by automatically adjusting the infusion rate of propofol - a general anesthetic - in response to an electroencephalogram (EEG) pattern called burst suppression. We also designed and implemented a computational patient model which interfaces with hardware and produces realistic EEG signals in response to propofol infusion. The computational patient model is used in hardware-in-the-loop studies to evaluate the behavior of our PCLC device under realistic perturbations. Finally, we have tested the performance of our PCLC device in rodents. Results from these studies suggest that closed-loop control of medically-induced coma in humans is feasible and robust. Consequently, our work produced a PCLC device and relevant pre-clinical evidence in support of a pilot clinical trial.