Measure Cardiac Output Using Ultrasound Dilution in Mechanically Ventilated Children

Post Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01662141
• Other study ID #: TSI-S-COstatus-13A-H
• Secondary ID: IRB
• Status: Completed
• Phase: N/A
• First received: August 6, 2012
• Last updated: August 7, 2012
• Start date: February 2010
• Est. completion date: September 2011

Study information

• Verified date: August 2012
• Source: Transonic Systems Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Post Cardiac Surgery

Locations

Country	Name	City	State
Sweden	Children Hospital, BUS, BIVA	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Transonic Systems Inc.

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of cardiac output by a new ultrasound dilution method in mechanically ventilated children after pediatric cardiac surgery.	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.	Measurements are made during a patient's stay with insitu catheters. The expected average stay is 3-4 days.	No