CLINICAL STUDIES REFERENCE GUIDE

November 2020

Sales offices:

North America: All other Countries:

NeuMeDx Inc. Manatec Biomedical 2014 Ford Road, Unit G 44, rue de Laborde Bristol, PA 19007 75008 PARIS USA FRANCE [email protected] [email protected] tel: (215) 826 9998 tel: +33 (3) 72 82 50 00 fax:(215) 826 8102 fax:+33 (1) 43 87 70 83

Manatec and PhysioFlow are registered trademarks

NEW STUDIES

Category Title Effect of New Zealand Blackcurrant Extract on Physiological Responses at Rest and during Brisk Walking in Southeast Asian Men: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study. Accuracy of Impedance Cardiography for Hemodynamic Assessment During Rest and Exercise in Wheelchair Rugby Players Évaluation de la réponse cardiaque lors d’une apnée statique chez les apnéistes expérimentés par rapport aux sujets témoins et analyse du débit cardiaque en temps réel par méthode non invasive : le PhysioFlow® Acute Cardiopulmonary Responses to Strength Training, High- Intensity Interval Training and Moderate-Intensity Continuous Training Physiology Single-leg Cycling Increases Limb-Specific Blood Flow Without Concurrent Increases in Normalised Power Output When Compared With Double-Leg Cycling in Healthy Middle-Aged Adults Performance evaluation of a portable bioimpedance monitor for measuring hemodynamic changes in athletes during a head-up tilt test Metabolic and Cardiovascular Responses on a Novel, Whole Body Exercise Device Compared to a Cycle Ergometer Effects of surgical and FFP2/N95 face masks on cardiopulmonary exercise capacity Quantifying the effects of four weeks of low-volume high-intensity sprint interval training on V̇ O2max through assessment of

Reproducibility/electrode Repeatability of impedance cardiography in the measurement of placement cardiovascular hemodynamics during exercise

Manatec and PhysioFlow are registered trademarks

Changes in exercise capactiy of frailest patients with failure treated with standard exercise 1 recommandations versus response to exercise: a pilot study. Cardiopulmonary Exercise Testing, Impedance Cardiography, and Reclassification of Risk in Patients Referred for Heart Failure Evaluation Cardiac Performance Assessment During Cardiopulmonary Exercise Test Can Improve the Management of Children With Repaired Congenital Heart Disease Noninvasive investigation of the cardiodynamic response to 6MWT in Cardiology people after stroke using impedance cardiography Nocturnal thoracic volume overload and post-discharge outcomes in patients hospitalized for acute heart failure The Effect of Carotid Chemoreceptor Inhibition on Exercise Tolerance in Chronic Heart Failure The non-invasive evaluation of heart function in patients with an acute myocardial infarction: The role of impedance cardiography Changes in exercise capactiy of frailest patients with heart failure treated with standard exercise recommandations versus stroke volume response to exercise: a pilot study Exercise Intolerance in Comorbid COPD and Heart Failure: The Role of Impaired Aerobic Function Left Ventricular Function Before and After Aerobic Exercise Training in Women With Pulmonary Arterial Hypertension Limited usefulness of resting hemodynamic assessments in predicting Lung disease and exercise capacity in hypertensive patients internal medicine Exercise impedance cardiography reveals impaired hemodynamic responses to exercise in hypertensives with dyspnea Multiparameter assessment of exercise capacity in patients with arterial hypertension Effects of lung deflation induced by tiotropium/olodaterol on the cardiocirculatory responses to exertion in COPD Stroke volume and cardiac output measurement in cardiac patients Thermodilution/echo- during a rehabilitation program: comparison between tonometry, doppler/rest impedancemetry and Determination of Cardiac Output in Pulmonary Hypertension Using Impedance Cardiography Cardiac output with modified cardio-impedance against inert gas Fick principle/exercise rebreathing during sub-maximal and maximal cycling exercise in healthy and fit subjects Cardiac output measurement during exercise in COPD: A comparison of dye dilution and impedance cardiography. The Utility of Impedance Cardiography in Hemodynamic Monitoring Intensive care of Patients With Sepsis

Manatec and PhysioFlow are registered trademarks

TABLE OF CONTENTS INTRODUCTION ...... 13 1 VALIDATIONS ...... 14 1.1 FICK PRINCIPLE/EXERCISE ...... 15  A New Impedance Cardiograph Device for the Non-invasive Evaluation of Cardiac Output at Rest and During Exercise: Comparison with the "Direct" Fick Method ...... 15  Non-invasive Cardiac Output Evaluation during a Maximal Progressive Exercise Test, Using a New Impedance Cardiograph Device...... 16  Measurements of Cardiac Output during Constant Exercises: Comparison of Two Non-Invasive Techniques ...... 17  Does Thoracic Bioimpedance Accurately Determine Cardiac Output in COPD patients during Maximal or Intermittent Exercise? ...... 18  Reliability of Peak VO(2) and Maximal Cardiac Output Assessed using Thoracic Bioimpedance in Children ...... 20  Does Advanced Cardiac Impedance Technology Accurately Measure Cardiac Output During Submaximal Steady State Exercise? ...... 21  The Ergogenic Effect of Recombinant Human Erythropoietin on VO2max Depends on the Severity of Arterial Hypoxemia ...... 22  Poor accuracy of noninvasive cardiac output monitoring using bioimpedance cardiography [PhysioFlow(R)] compared to magnetic resonance imaging in pediatric patients ...... 24  Evaluation of Impedance Cardiography for Measurement of Stroke Volume in Congenital Heart Disease...... 26  Evaluation of two methods for continuous cardiac output assessment during exercise in chronic heart failure patients ...... 27  Cardiac output during exercise: A comparison of four methods ...... 28  Comparison of Thoracic Bioimpedance with Acetylene Uptake for Measuring Cardiac Output...... 29  Reliability of exercise cardiac output measurement in COPD using impedancemetry: comparison with CO2 and inert gas rebreathing...... 30  Cardiac output measurement during exercise in COPD: A comparison of dye dilution and impedance cardiography ...... 31  Cardiac output with modified cardio-impedance against inert gas rebreathing during sub-maximal and maximal cycling exercise in healthy and fit subjects ...... 33  Determination of Cardiac Output in Pulmonary Hypertension Using Impedance Cardiography ...... 35 1.2 THERMODILUTION/ECHO-DOPPLER/REST ...... 37  Cardiac Output Measurements: Comparison between a New Transthoracic Electrical Bioimpedance Method (Physioflow™) and the Swan-Ganz Method (Continuous Cardiac Output or Bolus Technique) ...... 37

Manatec and PhysioFlow are registered trademarks

 Conclusion of the report on PhysioFlow Studies performed at MUSC Charleston, SC and UPMC Pittsburgh, PA, 2007 ...... 38  Value of Impedance Cardiography in Pulmonary Hypertension ...... 39  Value of Impedance Cardiography in Patients Studied for Pulmonary Hypertension ...... 40  The PhysioFlow Thoracic Impedancemeter Is Not Valid for the Measurements of Cardiac Hemodynamic Parameters in Chronic Anemic Patients ...... 41  Stroke Volume Variation Measured by Impedance Cardiography During Passive Leg Raising to Assess Fluid Responsiveness After ...... 42  Validation of impedance cardiography in pulmonary arterial hypertension ...... 44  Accuracy of impedance cardiography to measure cardiac output at rest in pulmonary hypertension ...... 45  Cardiac output measurement during exercise in COPD: A comparison of dye dilution and impedance cardiography ...... 46  Stroke volume and cardiac output