Non-Invasive Venous waveform Analysis (NIVA) for volume assessment during complex cranial vault reconstruction: A proof-of-concept study in children.

BACKGROUND: Non-Invasive Venous waveform Analysis (NIVA) is novel technology that captures and analyzes changes in venous waveforms from a piezoelectric sensor on the wrist for hemodynamic volume assessment. Complex cranial vault reconstruction is performed in children with craniosynostosis and is associated with extensive blood loss, potential life-threatening risks, and significant morbidity. In this preliminary study, we hypothesized that NIVA will provide a reliable, non-invasive, quantitative assessment of intravascular volume changes in children undergoing complex cranial vault reconstruction. OBJECTIVE: To present proof-of-concept results of a novel technology in the pediatric population. METHODS: The NIVA prototype was placed on each subject's wrist, and venous waveforms were collected intraoperatively. Estimated blood loss and fluid/blood product administration were recorded in real time. Venous waveforms were analyzed into a NIVA value and then correlated, along with mean arterial pressure (MAP), to volume changes. Concordance was quantified to determine if the direction of change in volume was similar to the direction of change in MAP or change in NIVA. RESULTS: Of 18 patients enrolled, 14 had usable venous waveforms, and there was a significant correlation between change in NIVA value and change in volume. Change in MAP did not correlate with change in volume. The concordance between change in MAP and change in volume was less than the concordance between change in NIVA and change in volume. CONCLUSION: NIVA values correlate more closely to intravascular volume changes in pediatric craniofacial patients than MAP. This initial study suggests that NIVA is a potential safe, reliable, non-invasive quantitative method of measuring intravascular volume changes for children undergoing surgery.

Non-invasive venous waveform analysis (NIVA) for volume assessment in patients undergoing hemodialysis: an observational study.

BACKGROUND: Accurate assessment of volume status to direct dialysis remains a clinical challenge. Despite current attempts at volume-directed dialysis, inadequate dialysis and intradialytic hypotension (IDH) are common occurrences. Peripheral venous waveform analysis has recently been developed as a method to accurately determine intravascular volume status through algorithmic quantification of changes in the waveform that occur at different volume states. A noninvasive method to capture peripheral venous signals is described (Non-Invasive Venous waveform Analysis, NIVA). The objective of this proof-of-concept study was to characterize changes in NIVA signal with dialysis. We hypothesized that there would be a change in signal after dialysis and that the rate of intradialytic change in signal would be predictive of IDH. METHODS: Fifty subjects undergoing inpatient hemodialysis were enrolled. A 10-mm piezoelectric sensor was secured to the middle volar aspect of the wrist on the extremity opposite to the access site. Signals were obtained fifteen minutes before, throughout, and up to fifteen minutes after hemodialysis. Waveforms were analyzed after a fast Fourier transformation and identification of the frequencies corresponding to the cardiac rate, with a NIVA value generated based on the weighted powers of these frequencies. RESULTS: Adequate quality (signal to noise ratio > 20) signals pre- and post- dialysis were obtained in 38 patients (76%). NIVA values were significantly lower at the end of dialysis compared to pre-dialysis levels (1.203 vs 0.868, p < 0.05, n = 38). Only 16 patients had adequate signals for analysis throughout dialysis, but in this small cohort the rate of change in NIVA value was predictive of IDH with a sensitivity of 80% and specificity of 100%. CONCLUSIONS: This observational, proof-of-concept study using a NIVA prototype device suggests that NIVA represents a novel and non-invasive technique that with further development and improvements in signal quality may provide static and continuous measures of volume status to assist with volume directed dialysis and prevent intradialytic hypotension.