Hemodynamics Clinical Trial
Official title:
Hemodynamic Monitoring of Newborn Infants With Impedance Cardiography Versus Echocardiography; a Validation Study
Background:
Impedance cardiography (ICG) is a noninvasive method for continuous left cardiac output
monitoring based on measurement of thoracic electrical bioimpedance. The objective of this
study is to validate an ICG device by investigating the agreement in cardiac output (CO; left
ventricular output x heart rate) measurements performed by ICG and echocardiography. The ICG
device (PhysioFlow) has a new filter technology reducing signal noise and enabling
measurements in patients who are moving freely.
Material and Methods
- Design: Prospective observational study.
- Inclusion: 30 healthy term infants between 24 and 48 hours of age, after parental
consent
- Methods: Continuous measurement with ICG over a 30 min period and point of care
echocardiography
- Primary outcome: Agreement (bis and precision) between measurement of CO with ICG and
echocardiography.
- Secondary outcomes: Agreement between other echocardiographic indices of myocardial
function and ICG parameters (early diastolic filling ratio, cardiac index, ventricular
ejection time and left cardiac work index).
- Statistics: Agreement between ICG and echocardiography data will be evaluated using
Bland-Altman statistics, including the calculation of mean bias (average difference
between measurements) with corresponding standard deviation and lower and upper limits
of agreements (95% confidence interval).
n/a
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