Noninvasive Measurement of CO Using Impedance Cardiography in Patients With CHD

Completed

Conditions studied: Congenital Heart Disease

In brief

This study will test the capability of a non-invasive instrument (the PhysioFlow impedance cardiography instrument) to measure cardiac output in patients with congenital heart disease (CHD). This instrument works by placing electrodes on the skin of a patient and measuring electrical impedance through the chest, which is proportional to blood volume and blood flow at any given time. The instrument has been validated in patients with structurally normal hearts, but in the only two studies using it for patients with CHD, it was deemed too inaccurate for clinical use. The manufacturer of the device would require access to data on the patients in order to improve its accuracy, and that has not been feasible thus far. This study would begin by comparing cardiac output based on the PhysioFlow monitor to standard techniques, then after possible changes to the instrument to enhance accuracy, would test the instrument again in the same way.

Key facts

Study ID

NCT02326649

Run by

University of California, San Diego

People needed

21

Starts

2014-12-01

Expected to finish

2016-03-01

Last updated by the study team

2017-04-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any form of congenital heart disease
• Any age

You may not qualify if…

• Subjects with significant clinical skin reactions to electrodes such as excessive pain and/or skin inflammation, or significant previous skin reaction
• Subjects who are not able to provide consent
• Subjects with pacemaker

Where it is running

• Rady Children's Hospital — San Diego, California, United States

Full record on ClinicalTrials.gov

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