Validation of Minimally Invasive Ultrasound Indicator Dilution Technique in Critically Ill Children

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.

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Key information

Conditions

Cardiac Output

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

To determine the accuracy of cardiac index measured by ultrasound dilution when compared to the gold-standard Fick technique.

Time frame: 5-8 minutes minimum

Secondary outcomes

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.

Time frame: 5-8 minutes minimum

Sponsors and collaborators

Lead sponsor

Transonic Systems Inc.

Industry

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Validation of a Novel, Minimally Invasive Ultrasound Indicator Dilution Technique for Measuring Cardiac Index in Critically Ill Children

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Feb 26, 2009
Registry last updated: May 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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