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

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          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.

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          Most cited references22

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          Early reversal of pediatric-neonatal septic shock by community physicians is associated with improved outcome.

          Experimental and clinical studies of septic shock support the concept that early resuscitation with fluid and inotropic therapies improves survival in a time-dependent manner. The new American College of Critical Care Medicine-Pediatric Advanced Life Support (ACCM-PALS) Guidelines for hemodynamic support of newborns and children in septic shock recommend this therapeutic approach. The objective of this study was to determine whether early septic shock reversal and use of resuscitation practice consistent with the new ACCM-PALS Guidelines by community physicians is associated with improved outcome. A 9-year (January 1993-December 2001) retrospective cohort study was conducted of 91 infants and children who presented to local community hospitals with septic shock and required transport to Children's Hospital of Pittsburgh. Shock reversal (defined by return of normal systolic blood pressure and capillary refill time), resuscitation practice concurrence with ACCM-PALS Guidelines, and hospital mortality were measured. Overall, 26 (29%) patients died. Community physicians successfully achieved shock reversal in 24 (26%) patients at a median time of 75 minutes (when the transport team arrived at the patient's bedside), which was associated with 96% survival and >9-fold increased odds of survival (9.49 [1.07-83.89]). Each additional hour of persistent shock was associated with >2-fold increased odds of mortality (2.29 [1.19-4.44]). Nonsurvivors, compared with survivors, were treated with more inotropic therapies (dopamine/dobutamine [42% vs 20%] and epinephrine/norepinephrine [42% vs 6%]) but not increased fluid therapy (median volume; 32.9 mL/kg vs 20.0 mL/kg). Resuscitation practice was consistent with ACCM-PALS Guidelines in only 27 (30%) patients; however, when practice was in agreement with guideline recommendations, a lower mortality was observed (8% vs 38%). Early recognition and aggressive resuscitation of pediatric-neonatal septic shock by community physicians can save lives. Educational programs that promote ACCM-PALS recommended rapid, stepwise escalations in fluid as well as inotropic therapies may have value in improving outcomes in these children.
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            Anesthesia-related cardiac arrest in children: update from the Pediatric Perioperative Cardiac Arrest Registry.

            The initial findings from the Pediatric Perioperative Cardiac Arrest (POCA) Registry (1994-1997) revealed that medication-related causes, often cardiovascular depression from halothane, were the most common. Changes in pediatric anesthesia practice may have altered the causes of cardiac arrest in anesthetized children. Nearly 80 North American institutions that provide anesthesia for children voluntarily enrolled in the Pediatric Perioperative Cardiac Arrest Registry. A standardized data form for each perioperative cardiac arrest in children
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              Predicting Fluid Responsiveness in Children : A Systematic Review

              Administration of fluid to improve cardiac output is the mainstay of hemodynamic resuscitation. Not all patients respond to fluid therapy, and excessive fluid administration is harmful. Predicting fluid responsiveness can be challenging, particularly in children. Numerous hemodynamic variables have been proposed as predictors of fluid responsiveness. Dynamic variables based on the heart-lung interaction appear to be excellent predictors of fluid responsiveness in adults, but there is no consensus on their usefulness in children.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: InvestigationRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: ResourcesRole: SoftwareRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: ResourcesRole: SoftwareRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: InvestigationRole: MethodologyRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: ResourcesRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: SupervisionRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                8 July 2020
                2020
                : 15
                : 7
                : e0235933
                Affiliations
                [1 ] Department of Anesthesiology, Division of Pediatric Anesthesiology, Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center / Vanderbilt University School of Medicine, Nashville, Tennessee, United States of America
                [2 ] Department of Surgery, Vanderbilt University Medical Center / Vanderbilt University School of Medicine, Nashville, Tennessee, United States of America
                [3 ] VoluMetrix, LLC, Nashville, TN, United States of America
                [4 ] Department of Anesthesiology, Division of Cardiothoracic Anesthesiology, Vanderbilt University Medical Center / Vanderbilt University School of Medicine, Nashville, Tennessee, United States of America
                [5 ] Department of Surgery, Division of Vascular Surgery, Vanderbilt University Medical Center / Vanderbilt University School of Medicine, Nashville, Tennessee, United States of America
                [6 ] Department of Anesthesiology, Division of Critical Care Medicine, Vanderbilt University Medical Center / Vanderbilt University School of Medicine, Nashville, Tennessee, United States of America
                University of Alberta, CANADA
                Author notes

                Competing Interests: The intellectual property associated with this novel technology is held by Vanderbilt University Medical Center (VUMC) and licensed to VoluMetrix. VoluMetrix was not a funding source for this study. KMH is Founder, CEO and President of VoluMetrix and an inventor on intellectual property in the field of venous waveform analysis assigned to VUMC and licensed to VoluMetrix. CMB is Founder and CMO of VoluMetrix and an inventor on intellectual property in the field of venous waveform analysis assigned to VUMC and licensed to VoluMetrix. BDA, is CSO and owns stock in VoluMetrix and is an inventor on intellectual property in the field of venous waveform analysis assigned to VUMC and licensed to VoluMetrix and is married to the COO of VoluMetrix. JW is the Senior Software Engineer and owns stock in VoluMetrix. SSE was former CEO of VoluMetrix and an inventor on intellectual property in the field of venous waveform analysis assigned to VUMC and licensed to VoluMetrix. The remaining authors have no conflicts of interest to declare. These declarations do not alter our adherence to PLOS ONE policies on sharing data and materials.

                Author information
                http://orcid.org/0000-0003-4480-146X
                http://orcid.org/0000-0002-1924-8976
                http://orcid.org/0000-0002-3603-7185
                Article
                PONE-D-20-15303
                10.1371/journal.pone.0235933
                7343152
                32640004
                2ba4b37a-511a-4c3b-8a93-1b58af45a46d
                © 2020 Sobey et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 21 May 2020
                : 24 June 2020
                Page count
                Figures: 1, Tables: 1, Pages: 8
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/501100008982, National Science Foundation;
                Award ID: 1549576
                Award Recipient :
                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.
                Categories
                Research Article
                Medicine and Health Sciences
                Pediatrics
                Medicine and Health Sciences
                Surgical and Invasive Medical Procedures
                Pediatric Surgery
                Medicine and Health Sciences
                Surgical and Invasive Medical Procedures
                Medicine and Health Sciences
                Vascular Medicine
                Blood Pressure
                Medicine and Health Sciences
                Hematology
                Hemodynamics
                Biology and Life Sciences
                Anatomy
                Musculoskeletal System
                Body Limbs
                Arms
                Wrist
                Medicine and Health Sciences
                Anatomy
                Musculoskeletal System
                Body Limbs
                Arms
                Wrist
                Medicine and Health Sciences
                Critical Care and Emergency Medicine
                Resuscitation
                Biology and Life Sciences
                Anatomy
                Body Fluids
                Blood
                Blood Volume
                Medicine and Health Sciences
                Anatomy
                Body Fluids
                Blood
                Blood Volume
                Biology and Life Sciences
                Physiology
                Body Fluids
                Blood
                Blood Volume
                Medicine and Health Sciences
                Physiology
                Body Fluids
                Blood
                Blood Volume
                Custom metadata
                All relevant data are within the paper and its Supporting Information files.

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