Cardiac Function as Measured by Non-invasive Electrical Velocimetry Cardiac Monitor in Hospitalized Children
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Purpose
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.
| Condition |
|---|
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Cardiac Output Blood Pressure |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Pilot Study: Cardiac Function as Measured by Non-invasive Electrical Velocimetry Cardiac Monitor in Hospitalized Children From Acute Illness (Disease) to Recovery (Health). |
- 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 [ Time Frame: During hospitalization until discharge ] [ Designated as safety issue: No ]
- To establish age relevant hemodynamic norms as measured by the electrical velocimetry (EV) cardiac monitor for trend parameters [ Time Frame: Measurements obtain on day of discharge ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 186 |
| Study Start Date: | December 2009 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Elevated Mean Arterial Blood Pressure
Mean arterial pressure greater than 1 standard deviation above the mean based on age
|
|
Decrease Mean Arterial Blood Pressure
Mean arterial pressure greater than 1 standard deviation below the mean based on age
|
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Normal Mean Arterial Blood Pressure
Mean arterial pressure within the standard deviation of the mean based on age
|
Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Hospitalized children
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)
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Jackson Wong MD, Children Hospital Boston |
| ClinicalTrials.gov Identifier: | NCT01030445 History of Changes |
| Other Study ID Numbers: | 09-11-0597 |
| Study First Received: | December 10, 2009 |
| Last Updated: | June 22, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital Boston:
|
non-invasive cardiac output monitor electrical velocimetry Aesculon |
Icon pediatrics normal reference |
ClinicalTrials.gov processed this record on May 22, 2013