Non Invasive Measurement of Cardiac Index by Impedance Cardiography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 89
- Locations
- 2
- Primary Endpoint
- Comparison of CI measured by ICG and Thermodilution
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
suspected PH
Patients who undergo right heart catheterization for PH diagnosis undergo impedance cardiography
Intervention: Impedance cardiography (Other)
Outcomes
Primary Outcomes
Comparison of CI measured by ICG and Thermodilution
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported