CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Physioflowdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02326649
NCT02326649N/ACompleted

Noninvasive Measurement of Cardiac Output Using Impedance Cardiography in Patients With Congenital Heart Disease

University of California, San Diego·observational·Posted Dec 29, 2014·Updated Apr 12, 2017

In Brief

An observational study evaluating Physioflow for Congenital Heart Disease. Completed, enrolled 21 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 29, 2014
Enrollment StartDec 1, 2014
Primary CompletionFeb 1, 2016
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.5 years ago

Interventions

Physioflowdevice

impedance cardiography instrument that measures cardiac output non-invasively