How to “validate” newly developed cardiac output monitoring devices

Excerpt

In the past decade, technological advances have catalyzed the development of (advanced) hemodynamic monitoring devices from invasive towards less invasive methods. Almost every month a new device appears on the market claiming to measure or estimate hemodynamic variables in a minimal or non-invasive fashion. These devices allow clinicians to broaden the scope beyond traditional pressure-based hemodynamic monitoring and by now, flow(-related) variables such as cardiac output (CO) can be assessed this way in almost all patients in the anesthetic or critical care setting. Hopefully, these technological advancements prove advantageous in terms of patient outcome in the (near) future. However, an accurate and precise estimation of the assumed-to-be-measured hemodynamic variable is an absolute prerequisite before such new devices can be clinically implemented, or even before outcome-related studies can be performed. Additionally, given the (hemodynamic) heterogeneity of various patient populations (e.g. patients with septic shock versus patients with cardiogenic shock), both accuracy and precision should be investigated in the relevant patient population(s). Therefore, researchers all over the world are stimulated to perform comparison studies in which new devices, software versions or sensor revisions are compared with their clinical reference methods or “gold standards”, and journals are overflooded with manuscripts on such evaluation studies. …