Cardiac Function as Measured by Non-invasive Electrical Velocimetry Cardiac Monitor in Hospitalized Children

Study Overview
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Brief Summary
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To assess whether a non-invasive cardiac output monitor can follow heart function in children during treatments in the hospital. To establish a normal reference for children who are well and awake.

Detailed Description
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The aim of the study is to evaluate the ability of a new FDA-approved non-invasive Electrical Velocimetry (EV) cardiac monitor called AESCULON (Cardiotronic Inc, La Jolla CA) to detect and trend hemodynamic changes in hospitalized ambulatory pediatric patients during recovery from acute illness. We postulate that if the cardiac monitor can trend hemodynamic changes in hypertensive patients whose mean arterial pressure (MAP) decreases to normal levels, or hypotensive patients whose MAP increases to normal levels over several days, it may improve our understanding of different disease processes and allow us to improve care. We also seek to establish normative data for different measures provided by the AESCULON monitor - specifically cardiac output (CO) and systemic vascular resistance (SVR), which are the prime determinants of MAP.

Official Title
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A Pilot Study: Cardiac Function as Measured by Non-invasive Electrical Velocimetry Cardiac Monitor in Hospitalized Children From Acute Illness (Disease) to Recovery (Health).

Conditions
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Cardiac Output, Blood Pressure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical patients without complex medical history with expected hospital stay for less than 10 days Uncomplicated Medical Patients as define as (1) Previously healthy children or (2) Children with diagnosis of a single chronic medical disorder that is not associated with cardiac dysfunction Exclusion Criteria: Congenital heart disease with and without repair (includes PFO, ASD and PDA, cardiac valve disease or pulmonary hypertension Chronic lung disease (except asthma) Abnormal Hemoglobin (SSD)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elevated Mean Arterial Blood Pressure<br>Mean arterial pressure greater than 1 standard deviation above the mean based on age | |
| Decrease Mean Arterial Blood Pressure<br>Mean arterial pressure greater than 1 standard deviation below the mean based on age | |
| Normal Mean Arterial Blood Pressure<br>Mean arterial pressure within the standard deviation of the mean based on age | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To document trends in cardiac output (CO) and systemic vascular resistance (SVR) in subjects undergoing systematic changes in mean arterial pressure (MAP) and to assess intra-individual variability for those with normal blood pressure |  | During hospitalization until discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish age relevant hemodynamic norms as measured by the electrical velocimetry (EV) cardiac monitor for trend parameters |  | Measurements obtain on day of discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-invasive cardiac output monitor, electrical velocimetry, Aesculon, Icon, pediatrics, normal reference