Non-Invasive Venous waveform Analysis (NIVA) for monitoring blood loss in human blood donors and validation in a porcine hemorrhage model.

Abstract

There is an unmet need for a non-invasive approach to diagnose hemorrhage early, before changes in vital signs occur. Non-Invasive Venous waveform Analysis (NIVA) uses a unique physiological signal (the peripheral venous waveform) to assess intravascular volume. We hypothesized changes in the venous waveform would be observed with blood loss in healthy adult blood donors and characterized hemorrhage using invasive monitoring in a porcine model. Prospective observational study. American Red Cross donation center. 50 human blood donors and 12 non-donating controls; 7 Yorkshire pigs. A venous waveform capturing prototype (NIVA device) was secured to the volar aspect of the wrist in human subjects. A central venous catheter was used to obtain hemodynamic indices and venous waveforms were obtained using the prototype NIVA device over the saphenous vein during 400mL of graded hemorrhage in a porcine model. Venous waveforms were transformed from the time to the frequency domain. The ratiometric power contributions of the cardiac frequencies were used to calculate a NIVA value representative of volume status. A significant decrease in NIVA value was observed after 500mL of whole blood donation (p<.05). A ROC curve for the ability of the NIVA to detect 500mL of blood loss demonstrated an area under the curve (AUC) of 0.94. In the porcine model, change in NIVA value correlated linearly with blood loss and with changes in hemodynamic indices. This study provides proof-of-concept for a potential application of NIVA in detection of blood loss. NIVA represents a novel physiologic signal for detection of early blood loss that may be useful in early triage and perioperative management.