Noninvasive Pulse Contour Analysis for Hemodynamic Assessment in Patients With Chronic Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational [Patient Registry]

Summary: 
      Determination of hemodynamics plays an important role in the diagnosis of chronic heart
      failure. The gold standard is intermittent thermodilution via pulmonary artery catheter
      (PAC). Because of its invasiveness, there are certain risks of this method, e.g. injuries to
      the nerves and vessels, excessive bleedings, pneumothorax, cardiac arrhythmias etc.
      Noninvasive pulse contour Analysis (NPCA) is a new method which is able to determine
      hemodynamics noninvasively via a simple finger cuff. Advantages towards pulmonary artery
      Catheterization include a lower risk and an operator-Independent easy handling. Some studies
      investigated the accuracy, precision and trending abilities of noninvasive pulse contour
      analysis during anesthesia and in the intensive care unit, but there is no data available for
      its use in patients with chronic heart failure. The investigators therefore initiated this
      Trial to verify if NPCA is suitable for Determination of hemodynamics in patients with
      chronic heart failure.
    

Detailed description: 
      Determination of hemodynamics plays an important role in the diagnosis of chronic heart
      failure. The gold standard is intermittent thermodilution via pulmonary artery catheter
      (PAC). Because of its invasiveness, there are certain risks of this method, e.g. injuries to
      the nerves and vessels, excessive bleedings, pneumothorax, cardiac arrhythmias etc.
      Noninvasive pulse contour Analysis (NPCA) is a new method which is able to determine
      hemodynamics noninvasively via a finger cuff. Advantages towards pulmonary artery
      Catheterization include a lower risk and an operator-Independent easy handling. Some studies
      investigated the accuracy, precision and trend abilities of noninvasive pulse contour
      analysis during anesthesia and in the intensive care unit, but there is no data for its use
      in patients with chronic heart failure. The investigators therefore initiated this Trial to
      verify if NPCA is suitable for Determination of hemodynamics in patients with chronic heart
      failure. For NPCA the investigators use the CNAP monitor (CNSystems Medizintechnik AG). As a
      reference method the investigators use intermittent thermodilution via PAC (TD). Three
      averaged autocalibrated NPCA-CO-measurements are going to be validated against three averaged
      TD-CO-measurements. Moreover, measurements of cardiac index, stroke volume, systemic vascular
      resistance and a between-calibration-drift will be performed. The investigators will assess
      the accuracy and precision of the individual values.
    

Intervention name(s): Noninvasive pulse contour analysis; Pulmonary artery catheterization
Intervention type(s): Device; Device
Intervention description(s): For noninvasive pulse contour Analysis we use the CNAP-Monitor (CNSystems Medizintechnik AG, Graz, Austria); As a reference method we use the Goldstandard intermittent thermodilution via a PAC which is regularly performed during the patients Hospital stay
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic heart failure NYHA >= 2 based on a reduced left ventricular ejection
        fraction (LV-EF <= 45%).
      
Keywords: Hemodynamics; Noninvasive; Pulse contour analysis; Heart failure; Swan Ganz Catheterization; Pulmonary artery Catheter