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

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ClinicalTrials.gov Identifier: NCT01030445
Recruitment Status : Completed
First Posted : December 11, 2009
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Jackson Wong, Boston Children's Hospital

Brief Summary:
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 or disease
Cardiac Output Blood Pressure

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.

Study Type : Observational
Actual Enrollment : 83 participants
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).
Study Start Date : December 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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
Normal Mean Arterial Blood Pressure
Mean arterial pressure within the standard deviation of the mean based on age



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized children
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01030445


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital

Responsible Party: Jackson Wong, Associate Professor of Pediatrics, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT01030445     History of Changes
Other Study ID Numbers: 09-11-0597
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: June 2011

Keywords provided by Jackson Wong, Boston Children's Hospital:
non-invasive cardiac output monitor
electrical velocimetry
Aesculon
Icon
pediatrics
normal reference