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Measure Cardiac Output Using Ultrasound Dilution in Mechanically Ventilated Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01662141
First Posted: August 10, 2012
Last Update Posted: August 10, 2012
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.
Information provided by (Responsible Party):
Transonic Systems Inc.
  Purpose
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
Post Cardiac Surgery

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Transonic Systems Inc.:

Primary Outcome Measures:
  • 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.


Enrollment: 33
Study Start Date: February 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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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
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01662141


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

Publications:
Responsible Party: Transonic Systems Inc.
ClinicalTrials.gov Identifier: NCT01662141     History of Changes
Other Study ID Numbers: TSI-S-COstatus-13A-H
IRB ( Other Identifier: University Hospital in Lund )
First Submitted: August 6, 2012
First Posted: August 10, 2012
Last Update Posted: August 10, 2012
Last Verified: August 2012

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