Calibration and validation of a MCC/IMS prototype for exhaled propofol online measurement

Propofol is a commonly used intravenous general anesthetic. Multi-capillary column (MCC) coupled Ion mobility spectrometry (IMS) can be used to quantify exhaled propofol, and thus estimate plasma drug concentration. Here, we present results of the calibration and analytical validation of a MCC/IMS pre market prototype for propofol quantification in exhaled air. Calibration with a reference gas generator yielded an R-2 >= 0.99 with a linear array for the calibration curve from 0 to 20 ppb(v). The limit of quantification was 0.3 ppb(v), and the limit of detection was 0.1 ppb(v). The device is able to distinguish concentration differences >0.5 ppb(v), for the concentration range between 2 and 4 ppb(v), and >0.9 ppb(v) for the range between 28 and 30 ppb(v). The imprecision at 20 ppb(v) is 11.3% whereas it is 3.5% at a concentration of 40 ppb(v). The carry-over duration is 3 min. The MCC/IMS we tested provided online quantification of gaseous propofol over the clinically relevant range at measurement frequencies of one measurement each minute. (C) 2017 Elsevier B.V. All rights reserved.