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

NCT01460329 | Completed

• 1 other identifier: 11-1178
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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).

Conditions

Critical Illness; Pediatrics

Keywords

intensive care units; pediatric; cardiac index; Doppler Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Cardiac Index

  measured at the time of study

Study Arms (1)

USCOM Cardiac index

Device: Ultrasonic Cardiac Output Monitor (USCOM).

Interventions

Ultrasonic Cardiac Output Monitor (USCOM). DEVICE

This device is FDA approved and based on the principles of ECHO using continuous-wave Doppler ultrasound to measure cardiac output.

Also known as: USCOM

USCOM Cardiac index

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Children's Hospital

Chapel Hill, North Carolina, 27614, United States

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nina J Verdino, MD

  East Carolina University

  PRINCIPAL INVESTIGATOR

• Keith C Kocis, MD

  University of North Carolina, Chapel Hill

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 26, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 6, 2013

Record last verified: 2013-05

Locations

US (1)