Non Invasive Measurement of Cardiac Index by Impedance Cardiography

Not Applicable

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Other: Impedance cardiography

• Registration Number: NCT01607515
• Lead Sponsor: Medical University of Graz

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-05-30
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-07
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
suspected PH	Impedance cardiography	Patients who undergo right heart catheterization for PH diagnosis undergo impedance cardiography

Primary Outcome Measures

Name	Time	Method
Comparison of CI measured by ICG and Thermodilution	recruitment over 1.5 year (Data collection), followed by data analysis and interpretation (overall 2 yearsfrom start of recruitment)	assessment of the Specificity and sensitivity of ICG for CI measurement

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria