Evaluation of indigenously developed closed-loop automated blood pressure control system (claps): a preliminary study.

ABSTRACT

Closed-loop systems have been designed to assist anesthetists in controlling anesthetic drugs and also maintaining the stability of various physiological variables in the normal range. In the present study, we describe and clinically evaluated a novel closed-loop automated blood pressure control system (CLAPS) in patients undergoing cardiac surgery under cardiopulmonary bypass. Forty ASA II-IV adult patients undergoing elective cardiac surgery were randomly allocated to receive adrenaline, noradrenaline, phenylephrine and nitroglycerine (NTG) adjusted either through CLAPS (CLAPS group) or manually (Manual group). The desired target mean arterial blood pressure (MAP) for each patient in both groups was set by the attending anesthesiologist. The hemodynamic performance was assessed based on the percentage duration of time the MAP remained within 20% of the set target. Automated controller performances were compared using performance error criteria of Varvel (MDPE, MDAPE, Wobble) and Global Score. MAP was maintained a significantly longer proportion of time within 20% of the target in the CLAPS group (79.4% vs. 65.5% p < 0.001, 't' test) as compared to the manual group. Median absolute performance error, wobble, and Global score was significantly lower in the CLAPS group. Hemodynamic stability was achieved with a significantly lower dose of Phenyepherine in the CLAPS group (1870 µg vs. 5400 µg, p < 0.05, 't' test). The dose of NTG was significantly higher in the CLAPS group (3070 µg vs. 1600 µg, p-value < 0.05, 't' test). The cardiac index and left ventricular end-diastolic area were comparable between the groups. Automated infusion of vasoactive drugs using CLAPS is feasible and also better than manual control for controlling hemodynamics during cardiac surgery. Trial registration number and date This trial was registered in the Clinical Trial Registry of India under Registration Number CTRI/2018/01/011487 (Retrospective; registration date; January 23, 2018).