Non Invasive Measurement of Cardiac Index by Impedance Cardiography

Pulmonary Hypertension Clinical Trial

Official title:

Non Invasive Measurement of Cardiac Index by Impedance Cardiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01607515
• Other study ID #: 24-205 ex 11/12
• Status: Completed
• Phase: N/A
• First received: April 13, 2012
• Last updated: September 7, 2015
• Start date: March 2012
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial Summary

Pulmonary hypertension (PH) is defined as a pulmonary arterial mean pressure (meanPAP) ≥ 25 mmHg in the right heart catheterization.

There are different forms of PH defined in the classification of Dana Point 2008.

PH is diagnosed with right heart catheterization but there are other non invasive methods which can be used for screening like echocardiography, stress echocardiography and cardio pulmonary exercise testing.

For prognosis of PH patients the limitation of the pulmonary circulation is very important. Therefore the cardiac index (CI) is a good parameter for the right ventricular function. The gold standard for CI measures is the thermodilution, an invasive method performed during right heart catheterization.

Description:

In this study the investigators want to evaluate the impedance cardiography (ICG) as a non invasive method for CI measurement. An alternating current of max 400µA and 45 kHz is conducted through the body. The way of the smallest resistance is the blood in the aorta. The impedance changes with the pulsatile blood flow. Out of the Impedance change there can be calculated the CI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients who have right heart catheterization written informed consent

Exclusion Criteria:

• patients who don't have right heart catheterization no written informed consent

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Other:
• Impedance cardiography
noninvasive measure of cardiac index by impedance cardiography.

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of CI measured by ICG and Thermodilution	assessment of the Specificity and sensitivity of ICG for CI measurement	recruitment over 1.5 year (Data collection), followed by data analysis and interpretation (overall 2 yearsfrom start of recruitment)	No