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

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Completed
CT.gov ID
NCT01460329
Collaborator
(none)
22
Enrollment
1
Location
8
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Device: Ultrasonic Cardiac Output Monitor (USCOM).

Study Design

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 :
Oct 1, 2011
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm 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 Names:
  • USCOM

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cardiac Index [measured at the time of study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 UNC Children's Hospital Chapel Hill North Carolina United States 27614

    Sponsors and Collaborators

    • University of North Carolina, Chapel Hill

    Investigators

    • Principal Investigator: Nina J Verdino, MD, East Carolina University
    • Study Chair: Keith C Kocis, MD, University of North Carolina, Chapel Hill

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Oct 26, 2011
    Last Update Posted:
    May 6, 2013
    Last Verified:
    May 1, 2013
    Keywords provided by Nina Verdino, MD, Principal Investigator, University of North Carolina, Chapel Hill
    intensive care units
    pediatric
    cardiac index
    Doppler Ultrasonography
    Additional relevant MeSH terms:
    Critical Illness

    Study Results

    No Results Posted as of May 6, 2013