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Comparing Cardiac Output Measurements in Critically Ill Children Using USCOM and Transthoracic ECHO

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ClinicalTrials.gov Identifier: NCT01460329
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : May 6, 2013
Sponsor:
Information provided by (Responsible Party):
Nina Verdino, MD, University of North Carolina, Chapel Hill

Study Description
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Brief Summary:
The purpose of this study is to compare the accuracy and precision of two non-invasive methods of measuring cardiac output in critically ill children (<18 yrs). The participants will include any patient admitted to Pediatric intensive care unit (PICU) requiring a trans-thoracic ECHO (TTE) as part of their treatment plan. Measurements of intermittent cardiac output will be obtained and compared on participants using standard 2-D TTE and Ultrasound Cardiac Output Monitor (USCOM).

Condition or disease Intervention/treatment
Critical Illness Pediatrics Device: Ultrasonic Cardiac Output Monitor (USCOM).

Study Design
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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparing Cardiac Output Measurements in Critically Ill Children Using Ultrasonic Cardiac Output Monitor and Transthoracic Echocardiography.
Study Start Date : October 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012
Groups and Cohorts
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Group/Cohort Intervention/treatment
USCOM Cardiac index Device: Ultrasonic Cardiac Output Monitor (USCOM).
This device is FDA approved and based on the principles of ECHO using continuous-wave Doppler ultrasound to measure cardiac output.
Other Name: USCOM


Outcome Measures
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Primary Outcome Measures :
  1. Cardiac Index [ Time Frame: measured at the time of study ]

Eligibility Criteria
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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subjects for this study can be either male or female and not limited by race or ethnicity. They will include critically ill pediatric patients, less than 18 yrs of age, being treated in the Pediatric intensive care unit.
Criteria

Inclusion Criteria:

  • Any UNC PICU patient <18 yrs requiring a transthoracic ECHO (TTE) as standard of care.
  • Gestational age >36 weeks
  • Wt > 2 kg
  • Written informed parental permission

Exclusion Criteria:

  • Any patient with known unrepaired intracardiac shunt lesion (ASD,PDA,VSD)
  • any post operative patient with delayed closure of chest
  • parental refusal to participate
Contacts and Locations
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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): NCT01460329


Locations
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United States, North Carolina
UNC Children's Hospital
Chapel Hill, North Carolina, United States, 27614
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Nina J Verdino, MD East Carolina University
Study Chair: Keith C Kocis, MD University of North Carolina, Chapel Hill
More Information
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Responsible Party: Nina Verdino, MD, Principal Investigator, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01460329    
Other Study ID Numbers: 11-1178
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: May 6, 2013
Last Verified: May 2013
Keywords provided by Nina Verdino, MD, University of North Carolina, Chapel Hill:
intensive care units
pediatric
cardiac index
Doppler Ultrasonography
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes