AUTHOR=Bellal Mathieu , Lelandais Julien , Chabin Thomas , Heudron Aurélie , Gourmelon Thomas , Bauduin Pierrick , Cuchet Pierre , Daubin Cédric , De Carvalho Ribeiro Célia , Delcampe Augustin , Goursaud Suzanne , Joret Aurélie , Mombrun Martin , Valette Xavier , Cerasuolo Damiano , Morello Rémy , Mordel Patrick , Chaillot Fabien , Dutheil Jean Jacques , Vivien Denis , Du Cheyron Damien 

TITLE=Calibration trial of an innovative medical device (NEVVA©) for the evaluation of pain in non-communicating patients in the intensive care unit

JOURNAL=Frontiers in Medicine

VOLUME=Volume 11 - 2024

YEAR=2024

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1309720

DOI=10.3389/fmed.2024.1309720

ISSN=2296-858X

ABSTRACT=Background: 
Pain management is an essential and complex issue for non-communicative patients undergoing sedation in the Intensive Care Unit (ICU). The Behavioral Pain Scale (BPS), although not perfect for assessing behavioral pain, is the gold standard based partly on clinical facial expression. Therefore, there is therefore a strong need for a more valid innovative medical device – NEVVA© – an automated pain assessment tool based on facial expression in critically ill patients.
Methods: 
In this prospective pilot study, we recorded the facial expressions of critically ill patients in the medical ICU of Caen University Hospital using the iPhone and Smart Motion Tracking System (SMTS) software with the Facial Action Coding System (FACS system) to measure human facial expressions metrically during sedation weaning. Analyses were recorded continuously, and BPS scores were collected hourly over two 8-hour periods per day during three consecutive days. For this first stage, calibration of the innovative NEVVA© medical device algorithm was obtained by comparison with the reference pain scale (BPS).
Results: 
Thirty participants were enrolled between march and july 2022. To assess the acute severity of illness, the Sequential Organ Failure Assessment (SOFA) and the Simplified Acute Physiology Score (SAPS II) were recorded on ICU admission and were 9 and 47, respectively. All participants had deep sedation, assessed by a RASS score less than or equal to -4, at the time of inclusion. One thousand and six BPS recordings were obtained, and 130 recordings were retained for final calibration: 108 BPS recordings corresponding to absence of pain and 22 BPS recordings corresponding to presence of pain. Due to the small size of the dataset a Leave-One-Subject-Out Cross-Validation (LOSO-CV) strategy was used, and the training results can give the ROC curve with an AUC of 0.792. This model has a sensitivity of 81,8 % and a specificity of 72,2 %.
Conclusions: 
This pilot study calibrated the NEVVA© medical device and put into perspective the feasibility of continuous facial expression analysis for pain monitoring in ICU patients. The next step will be to correlate this device with the BPS scale.