E!115487/COD15 Smart Microcirculation Monitoring for Optimal Treatment and Care of ICU Patients

Patients admitted to the Intensive Care Unit (ICU) need constant monitoring of the body's circulation to diagnose shock and prevent organ failure. Identifying the type of shock (hypovolemic, cardiogenic or distributive) is relevant as the treatment strategy in the various conditions can be very different to shorten shock duration and reduce organ damage. Clinicians can today only consider systemic hemodynamic changes (i.e. blood pressure, ECG, oxygen saturation), and have no opportunity to assess microcirculation and the effect of resuscitation therapies by tissue perfusion (lack of blood filling). We will develop a platform together with international partners in microcirculation, optics and clinical testing. The platform should be used clinically and enables a precise assessment of hemodynamics, oxygen availability and inflammatory function of the microcirculation. Software will be developed to quantify microcirculation diffusion and provide direct insight into tissue perfusion, by including assessment of two key resuscitation parameters and by integrating AI algorithms to translate patient data into evidence-based decision support. The platform will include: 1) a dark field microscopy and new optical lens for spectrophotometric oxygen availability measurement 2) a user interface that enables an optimal sublingual (under the tongue) area and optimal pressure for precise imaging. The platform will be validated on people at Nancy University Hospital, CHRU. This will be a necessary study for CE marking.

Once admitted to the ICU, patients need constant monitoring of their body circulation for shock diagnosis and to prevent organ failure. Identifying the type of shock (hypovolemic, cardiogenic or distributive) is of most relevance for shortening shock duration and reducing organ damage. Clinicians can only assess systemic hemodynamic alterations (ie blood pressure, ECG, oxygen saturation), and are hindered by their inability to assess microcirculation and the effect of resuscitation therapies in tissue perfusion. This leads to 72% of patients dying due to microcirculation impairment. Current devices assessing microcirculation are research only. Their clinical feasibility is limited by the extensive labour required for image analysis and extrapolation of relevant parameters and the cut-off values for these parameters which need to be defined to describe abnormalities. MICRO-MONITOR will meet this need by developing Spectrascan. The consortium builds from Active Medical’s software MicroTools, able to quantify microcirculatory diffusion and provide direct insight into tissue perfusion. The software will be improved by including the assessment of two pivotal resuscitation parameters and by integrating AI algorithms to translate the patient’s data into evidence-based decision support. The hardware will present 1) a dark-field microscopy and novel optical lens for spectrophotometric measurement of oxygen availability (OptaSensor, OPT) and 2) a user interface that facilitates optimal sublingual area and pressure for precise imaging (Inventas, INV). The analysis will be integrated in existing ICU monitors. The main result is a human-validated (Nancy University Hospital, CHRU) device ready to enter a pivotal study required for CE-marking.