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

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.

Study Overview

• Status: Completed
• Conditions: Post Cardiac Surgery

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 Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, SE-221 85
    • Children Hospital, BUS, BIVA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric Patients (< 15) in the ICU

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Transonic Systems Inc.
• Investigators: Principal Investigator: Lars Lindberg, MD, PhD, University Hospital in Lund

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: August 6, 2012
• First Submitted That Met QC Criteria: August 7, 2012
• First Posted (ESTIMATE): August 10, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 10, 2012
• Last Update Submitted That Met QC Criteria: August 7, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Cardiac output; Perivascular Probe
• Other Study ID Numbers: TSI-S-COstatus-13A-H; IRB (University Hospital in Lund)