Status:
COMPLETED
Validation of Minimally Invasive Ultrasound Indicator Dilution Technique in Critically Ill Children
Lead Sponsor:
Transonic Systems Inc.
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiac Output
Eligibility:
All Genders
Up to 18 years
Brief Summary
A novel method to measure cardiac index based on ultrasound indicator dilution technology (UIDT) has been developed by Transonic Systems Inc. (Ithaca, NY, USA). The method overcomes many of the limita...
Eligibility Criteria
Inclusion
- Age: less than 18 years.
- Admission to the CICU (Cardiac Intensive Care Unit) (8S) or MISICU (Medical-Surgical Intensive Care Unit) (7S) of the Children's Hospital Boston.
- Presence of a central venous catheter with its tip in the superior vena cava or a catheter in the pulmonary artery, documented by radiography.
- Requirement for mechanical ventilation via an endotracheal or tracheostomy tube.
- Presence of an arterial catheter.
- Patients must have a two ventricle circulation.
Exclusion
- Endotracheal tube leak of greater than 10%.
- A significant air leak around the endotracheal tube makes VO2 impossible to measure.
- Presence of relevant intracardiac shunt.
- Intracardiac shunt will decrease the area under the arterial dilution curve unpredictably, making cardiac index calculations unreliable.
- A patent foramen ovale and a single ventricular septal defect less than or equal to 2mm or an atrial septal defect less than or equal to 3mm will be considered irrelevant for the purposes of this study.
- Previous enrollment in an incompatible research study.
- Current or prior diagnosis of heparin induced thrombocytopenia.
- A small amount of heparin is required to flush the extracorporeal AV (Arteriovenous) loop that is required for the measurements.
- Pneumothorax with ongoing air leak.
- An air leak will invalidate the measurement of VO2.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00852254
Start Date
June 1 2008
End Date
May 1 2011
Last Update
May 27 2016
Active Locations (1)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115