Progress in the validation of nociception monitoring in guiding intraoperative analgesic therapy.

Abstract

This article summarizes the current level of validation for several nociception monitors using a categorized validation process to facilitate the comparison of performance. Nociception monitors improve the detection of a shift in the nociception and antinociception balance during anesthesia, guiding perioperative analgesic therapy. A clear overview and comparison of the validation process for these monitors is missing. Within a 2-year time-frame, we identified validation studies for four monitors [analgesia nociception index (ANI), nociception level monitor (NOL), surgical pleth index (SPI), and pupillometry]. We categorized these studies in one out of six mandatory validation steps: developmental studies, clinical validation studies, pharmacological validation studies, clinical utility studies, outcome improvement studies and economical evaluation studies. The current level of validation for most monitors is mainly focused on the first three categories, whereas ANI, NOL, and SPI advanced most in the availability of clinical utility studies and provide confirmation of a clinical outcome improvement. Analysis of economical value for public health effects is not yet publicly available for the studied monitors. This review proposes a stepwise structure for validation of new monitoring technology, which facilitates comparison between the level of validation of different devices and identifies the need for future research questions.