Noninvasive Pulse Contour Analysis for Hemodynamic Assessment in Patients With Chronic Heart Failure

Conditions

Heart Failure

Keywords

Hemodynamics, Noninvasive, Pulse contour analysis, Heart failure, Swan Ganz Catheterization, Pulmonary artery Catheter

Brief 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.

Related papers

No related papers found yet.

Interventions

DEVICENoninvasive pulse contour analysis

For noninvasive pulse contour Analysis we use the CNAP-Monitor (CNSystems Medizintechnik AG, Graz, Austria)

DEVICEPulmonary artery catheterization

As a reference method we use the Goldstandard intermittent thermodilution via a PAC which is regularly performed during the patients Hospital stay

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

No

Inclusion criteria

* chronic heart failure NYHA \>= 2 based on a reduced left ventricular ejection fraction (LV-EF \<= 45%) * written consent

Exclusion criteria

* high-grade tricuspid insufficiency * implantation of a ventricular assist device (VAD) * NIBP difference \>= 20 mmHg between left and right arm before investigation

Design outcomes

Primary

Measure	Time frame	Description
Cardiac Output (l/min)	1 day	Three repeated and averaged measurements in a row of both methods within a range of \<= 10%

Secondary

Measure	Time frame	Description
Cardiac index (l/min/m2)	1 day	Three repeated and averaged measurements in a row of both methods within a range of \<= 10%
Stroke volume (ml)	1 day	Three repeated and averaged measurements in a row of both methods within a range of \<= 10%
Systemic vascular resistance (dyn*sec/cm5)	1 day	Three repeated and averaged measurements in a row of both methods within a range of \<= 10%

Other

Measure	Time frame	Description
Between-Calibration-Drift	1 day	One measurement before and after a new calibration including finger change

Countries

Germany

Outcome results

None listed