Measure Cardiac Output Using Ultrasound Dilution in Mechanically Ventilated Children

Completed

• Conditions: Post Cardiac Surgery

• Registration Number: NCT01662141
• Lead Sponsor: Transonic Systems Inc.

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.

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-08
• Study First Submitted: 2012-08-06
• Study First Submitted QC: 2012-08-07
• Last Update Submitted: 2012-08-07
• Study First Posted: 2012-08-10
• Last Update Posted: 2012-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Children Hospital, BUS, BIVA; 🇸🇪 Lund, Sweden