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Measure Cardiac Output Using Ultrasound Dilution in Mechanically Ventilated Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Transonic Systems Inc.
ClinicalTrials.gov Identifier:
NCT01662141
First received: August 6, 2012
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  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:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

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. ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 6, 2012
Last Updated: August 7, 2012
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013