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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460329
• Other study ID #: 11-1178
• Status: Completed
• Phase: N/A
• First received: October 24, 2011
• Last updated: May 3, 2013
• Start date: October 2011
• Est. completion date: June 2012

Study information

• Verified date: May 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Pediatrics

Intervention

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.

Locations

Country	Name	City	State
United States	UNC Children's Hospital	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Index		measured at the time of study	No