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Noninvasive Measurement of CO Using Impedance Cardiography in Patients With CHD

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ClinicalTrials.gov Identifier: NCT02326649
Recruitment Status : Completed
First Posted : December 29, 2014
Results First Posted : April 12, 2017
Last Update Posted : April 12, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Congenital Heart Disease Device: Physioflow

Detailed Description:

The measurement of cardiac output (CO) is important for a wide variety of patients under multiple conditions. At present, gold standard techniques for measurement of CO include velocity encoded phase contrast MRI. Both of these techniques are valid in patients with structural CHD. Disadvantages of these techniques include the requirement of significant time and expertise, and the high cost and anesthesia requirement. Accurate, non-invasive tools to measure CO could be extremely valuable for patients with CHD that require one-time of continuous monitoring of CO, such as during surgery, in intensive care settings, during other diagnostic testing, and during different physiologic states such as sleep and exercise. This study would begin by comparing cardiac output based on the PhysioFlow monitor to cardiac outout by MRI.

Impedance cardiography is performed by placing electrodes on the thorax and neck to measure electrical impedance over time. Cardiac output is derived from these measurements. The technique has been studied, validated, and used extensively in adults and has also been shown to be valid in children with structurally normal hearts. In contrast, recent studies of children with CHD have shown a relatively poor agreement between impedance cardiography and both thermodilution technique and velocity encoded phase contrast MRI. The reasons for the poor agreement in CHD patients is not yet understood. There are proprietary algorithms in each impedance device that use the raw data to calculate and report cardiac output. If the physiologic and/or anatomic differences of patients with CHD require changing the algorithm within each system to account for such differences, that needs to be done to each system. In order to do this, owners of any given device (PhysioFlow, NeuMeDx Inc. in this case) need access to the raw data in order to alter the algorithm. This study will involve a concerted effort between investigators at RCHSD, UCSD, and NeuMeDx

Study Design

Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Measurement of Cardiac Output Using Impedance Cardiography in Patients With Congenital Heart Disease
Study Start Date : December 2014
Primary Completion Date : February 2016
Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
CHD patients undergoing cardiac MRI without sedation Device: Physioflow
impedance cardiography instrument that measures cardiac output non-invasively

Outcome Measures

Primary Outcome Measures :
  1. Mean Difference in Stroke Volume Between CMR and SMIC [ Time Frame: 2 hours ]
    Mean difference in stroke volume (SV) between CMR and SMIC measurements in ml

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient with congenital heart disease that is undergoing cardiac MRI without anesthesia

Inclusion Criteria:

  • Any form of congenital heart disease
  • Any age

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326649

United States, California
Rady Children's Hospital
San Diego, California, United States, 92123
Sponsors and Collaborators
University of California, San Diego
More Information

Responsible Party: Dr. Christopher Davis, PI, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02326649     History of Changes
Other Study ID Numbers: 140550
First Posted: December 29, 2014    Key Record Dates
Results First Posted: April 12, 2017
Last Update Posted: April 12, 2017
Last Verified: February 2017

Keywords provided by Dr. Christopher Davis, University of California, San Diego:
cardiac output

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities