Design and validation of an intelligent patient monitoring and alarm system based on a fuzzy logic process model.

The process of patient care performed by an anaesthesiologist during high invasive surgery requires fundamental knowledge of the physiologic processes and a long standing experience in patient management to cope with the inter-individual variability of the patients. Biomedical engineering research improves the patient monitoring task by providing technical devices to measure a large number of a patient's vital parameters. These measurements improve the safety of the patient during the surgical procedure, because pathological states can be recognised earlier, but may also lead to an increased cognitive load of the physician. In order to reduce cognitive strain and to support intra-operative monitoring for the anaesthesiologist an intelligent patient monitoring and alarm system has been proposed and implemented which evaluates a patient's haemodynamic state on the basis of a current vital parameter constellation with a knowledge-based approach. In this paper general design aspects and evaluation of the intelligent patient monitoring and alarm system in the operating theatre are described. The validation of the inference engine of the intelligent patient monitoring and alarm system was performed in two steps. Firstly, the knowledge base was validated with real patient data which was acquired online in the operating theatre. Secondly, a research prototype of the whole system was implemented in the operating theatre. In the first step, the anaesthetists were asked to enter a state variable evaluation before a drug application or any other intervention on the patient into a recording system. These state variable evaluations were compared to those generated by the intelligent alarm system on the same vital parameter constellations. Altogether 641 state variable evaluations were entered by six different physicians. In total, the sensitivity of alarm recognition is 99.3%, the specificity is 66% and the predictability is 45%. The second step was performed using a research prototype of the system in anaesthesiological routine. The evaluation of 684 events yielded a sensitivity, specificity and predictability of the alarm recognition of more than 99%.