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

PLoS One. 2020 Jul 8;15(7):e0235933. doi: 10.1371/journal.pone.0235933. eCollection 2020.

Abstract

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.

Publication types

  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Arterial Pressure / physiology
  • Blood Loss, Surgical
  • Child
  • Child, Preschool
  • Craniosynostoses / surgery*
  • Craniosynostoses / therapy
  • Female
  • Fluid Therapy
  • Hemodynamics
  • Humans
  • Infant
  • Male
  • Plastic Surgery Procedures
  • Veins / physiology*

Grants and funding

This research work was supported by the National Science Foundation (NSF), grant number 1549576 (PI: KMH). VoluMetrix WAS NOT a funding organization. The funder (NSF) provided support in the form of salary support (KMH, BA, SE), and prototype development, but did not have a role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ sections.