Medical Devices: Evidence and Research (Nov 2024)
Initial Validation of the NOL Nociception Level Index® Monitoring System in Black and Multiracial People
Abstract
Rachel Weissbrod,1 Charlene Blake2 1Medasense Biometrics Ltd, Ramat Gan, Israel; 2Department of Anesthesia at the University of San Francisco, San Francisco, CA, USACorrespondence: Rachel Weissbrod, Medasense Biometrics, 4 hachilazon St, Ramat Gan, Israel, Email [email protected]: The NOL-Nociception Level Index® is a multiparameter index, based on artificial intelligence for the monitoring of nociception (physiological pain response) during anesthesia that has recently been authorized by the FDA. The monitor utilizes continuous streams of information from a finger probe comprising four sensors, including photoplethysmography, to provide a personalized nociception score on a scale of 0– 100. Recent studies have suggested racial bias in pulse oximeter measurements due to the effect of melanin levels on photoplethysmography measurements. Therefore, there is a need to clinically validate new monitoring technologies in patients of all skin tones. The performance of the NOL scale in 8 patients that self-identified as Black or multiracial was compared to a database of 447 consented patients, assessing the response to surgical events at different levels of intensity. The descriptive, pilot data suggest that NOL performance in Black and multiracial patients is not different from the performance shown for the large database. Larger studies utilizing recognized skin tone scales to ensure accurate assessment of skin pigmentation are planned for the future.Keywords: nociception monitoring, pain management, inequity in healthcare, patient monitoring