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

Boston Children's Hospital logo

Boston Children's Hospital

Status

Completed

Conditions

Cardiac Output
Blood Pressure

Study type

Observational

Funder types

Other

Identifiers

NCT01030445
09-11-0597

Details and patient eligibility

About

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.

Full 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.

Enrollment

83 patients

Sex

All

Volunteers

No Healthy Volunteers

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)

Trial design

83 participants in 3 patient groups

Elevated Mean Arterial Blood Pressure
Description:
Mean arterial pressure greater than 1 standard deviation above the mean based on age
Decrease Mean Arterial Blood Pressure
Description:
Mean arterial pressure greater than 1 standard deviation below the mean based on age
Normal Mean Arterial Blood Pressure
Description:
Mean arterial pressure within the standard deviation of the mean based on age

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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