Cardiac Output Clinical Trial
Official title:
Validation of a Novel, Minimally Invasive Ultrasound Indicator Dilution Technique for Measuring Cardiac Index in Critically Ill Children
Verified date | May 2016 |
Source | Transonic Systems Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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 limitations that have plagued the existing techniques used to measure cardiac
index in critically ill children.
In the proposed investigation, the investigators hope to validate a novel application of an
existing technology in critically ill infants and children. The primary aim of this study is
to determine the accuracy of cardiac index measured by UIDT when compared to the
gold-standard Fick technique. The primary hypothesis is that the average of three
consecutive measurements of cardiac index by UIDT will be accurate when compared to the Fick
technique. Secondary aims will be to determine the precision of the measurement, the
feasibility of the technique with regards to time required and any complications
encountered. An exploratory secondary aim of this study is to determine whether central
blood volume (CBV) derived from indicator transit time (ITT) correlates with central venous
pressure (CVP) and echocardiography derived measures of preload.
Status | Completed |
Enrollment | 9 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 18 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Boston | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Transonic Systems Inc. | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the accuracy of cardiac index measured by ultrasound dilution when compared to the gold-standard Fick technique. | 5-8 minutes minimum | No | |
Secondary | To determine the precision and feasibility of the measurements. Also to determine whether central blood volume (CBV) measured by ultrasound dilution correlates with central venous pressure (CVP) and echocardiography derived preload measures. | 5-8 minutes minimum | No |
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