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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Children's Hospital Boston.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01030445
First received: December 10, 2009
Last updated: June 22, 2011
Last verified: June 2011
  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
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).

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030445

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
  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 August 26, 2014