Cardiac Function as Measured by Non-invasive Electrical Velocimetry Cardiac Monitor in Hospitalized Children
A Pilot Study: Cardiac Function as Measured by Non-invasive Electrical Velocimetry Cardiac Monitor in Hospitalized Children From Acute Illness (Disease) to Recovery (Health).
1 other identifier
observational
83
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 10, 2009
CompletedFirst Posted
Study publicly available on registry
December 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJanuary 5, 2017
June 1, 2011
1.5 years
December 10, 2009
January 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
During hospitalization until discharge
Secondary Outcomes (1)
To establish age relevant hemodynamic norms as measured by the electrical velocimetry (EV) cardiac monitor for trend parameters
Measurements obtain on day of discharge
Study Arms (3)
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
Eligibility Criteria
Hospitalized children
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
December 10, 2009
First Posted
December 11, 2009
Study Start
December 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
January 5, 2017
Record last verified: 2011-06