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OpenTrials
Completed

NCT Number: NCT01662141

Measure Cardiac Output Using Ultrasound Dilution in Mechanically Ventilated Children

The measurement of cardiac output (CO) and hemodynamic pressures are vital for proper management of severely hemodynamic compromised patients. A new ultrasound dilution method (COstatus) for cardiac output measurement has been developed.

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Key information

Conditions

Post Cardiac Surgery

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children Hospital, BUS, BIVA

Lund, SE-221 85, Sweden

About this study

The thermodilution technique with a pulmonary artery catheter has been the standard in adult patients for cardiac output measurement. However, using pulmonary artery catheter remains a major clinical problem in children due to technical and size constraints.

COstatus measures changes in blood ultrasound velocity in an extracorporeal AV loop caused by body-temperature isotonic saline injected into the central vein and calculates cardiac output derived from a dilution curve.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children <15 kg admitted to pediatric cardiac surgery for corrective surgery and mechanically ventilated were eligible for the study if parents provided informed consent.

Exclusion criteria

  • Children with known significant tricuspid or mitral valve regurgitations or if it is detected by the preoperative transesophageal echocardiographic examination.
  • Children with persistent severe arrhythmias.
  • Children with remaining intracardiac shunts after surgery, which may adversely affect the measurement.

Treatment and study plan

Primary outcomes

  1. Measurement of cardiac output by a new ultrasound dilution method in mechanically ventilated children after pediatric cardiac surgery.

    Time frame: Measurements are made during a patient's stay with insitu catheters. The expected average stay is 3-4 days.

    To compare cardiac outputs measured with this new ultrasound dilution method with flowmetry (perivascular probe) using ultrasound transit time measured directly on the aorta in children < 15 kg of weight. Also to assess reliability of COstatus measurements in pediatric patients.

Sponsors and collaborators

Lead sponsor

Transonic Systems Inc.

Industry

Registry information

Official study title

Investigation of the Reliability to Measure Cardiac Output by a New Ultrasound Dilution Method in Mechanically Ventilated Children After Pediatric Cardiac Surgery

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 10, 2012
Registry last updated
Aug 10, 2012

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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