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

Comparing Cardiac Output Measurements in Critically Ill Children Using Ultrasonic Cardiac Output Monitor and Transthoracic Echocardiography.

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).

Study Overview

• Status: Completed
• Conditions: Critical Illness; Pediatrics
• Intervention / Treatment: Device: Ultrasonic Cardiac Output Monitor (USCOM).

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27614
      • UNC Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: USCOM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cardiac Index	measured at the time of study

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: October 24, 2011
• First Submitted That Met QC Criteria: October 24, 2011
• First Posted (ESTIMATE): October 26, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 6, 2013
• Last Update Submitted That Met QC Criteria: May 3, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: pediatric; intensive care units; cardiac index; Doppler Ultrasonography
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 11-1178