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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-06-30

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.

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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.

Conditions

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Cardiac Output Blood Pressure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Elevated Mean Arterial Blood Pressure

Mean arterial pressure greater than 1 standard deviation above the mean based on age

No interventions assigned to this group

Decrease Mean Arterial Blood Pressure

Mean arterial pressure greater than 1 standard deviation below the mean based on age

No interventions assigned to this group

Normal Mean Arterial Blood Pressure

Mean arterial pressure within the standard deviation of the mean based on age

No interventions assigned to this group

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)

Eligible Sex

ALL

Accepts Healthy Volunteers

No