Measure Cardiac Output Using Ultrasound Dilution in Mechanically Ventilated Children

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01662141

Enrollment

Registered

2012-08-10

Start date

2010-02-28

Completion date

2011-09-30

Last updated

2012-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Cardiac Surgery

Keywords

Cardiac output, Perivascular Probe

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 21 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Measurement of cardiac output by a new ultrasound dilution method in mechanically ventilated children after pediatric cardiac surgery.	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.

Countries

Sweden

Outcome results