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OpenTrials
Completed

NCT Number: NCT01460329

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

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).

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatrics

Age range

1 day–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UNC Children's Hospital

Chapel Hill, North Carolina, 27614, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: USCOM

Primary outcomes

  1. Cardiac Index

    Time frame: measured at the time of study

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 26, 2011
Registry last updated
May 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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