Measure Cardiac Output Using Ultrasound Dilution in Mechanically Ventilated Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01662141
Recruitment Status : Completed
First Posted : August 10, 2012
Last Update Posted : August 10, 2012
Information provided by (Responsible Party):
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.

Condition or disease
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
Actual Enrollment : 33 participants
Time Perspective: Prospective
Official Title: Investigation of the Reliability to Measure Cardiac Output by a New Ultrasound Dilution Method in Mechanically Ventilated Children After Pediatric Cardiac Surgery
Study Start Date : February 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  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.

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric Patients (< 15) in the ICU

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01662141

Children Hospital, BUS, BIVA
Lund, Sweden, SE-221 85
Sponsors and Collaborators
Transonic Systems Inc.
Principal Investigator: Lars Lindberg, MD, PhD University Hospital in Lund

Responsible Party: Transonic Systems Inc. Identifier: NCT01662141     History of Changes
Other Study ID Numbers: TSI-S-COstatus-13A-H
IRB ( Other Identifier: University Hospital in Lund )
First Posted: August 10, 2012    Key Record Dates
Last Update Posted: August 10, 2012
Last Verified: August 2012

Keywords provided by Transonic Systems Inc.:
Cardiac output
Perivascular Probe