Noninvasive Measurement of CO Using Impedance Cardiography in Patients With CHD

NCT02326649 | Completed Results

• 1 other identifier: 140550
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

cardiac output

Outcome Measures

Primary Outcomes (1)

• Mean Difference in Stroke Volume Between CMR and SMIC

  Mean difference in stroke volume (SV) between CMR and SMIC measurements in ml

  2 hours

Study Arms (1)

CHD patients undergoing cardiac MRI without sedation

Device: Physioflow

Interventions

Physioflow DEVICE

impedance cardiography instrument that measures cardiac output non-invasively

CHD patients undergoing cardiac MRI without sedation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient with congenital heart disease that is undergoing cardiac MRI without anesthesia

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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Rady Children's Hospital

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Christopher Davis
• Organization: UCSD

cdavis@rchsd.org

8589665855

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 29, 2014
• Study Start: December 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 12, 2017
• Results First Posted: April 12, 2017

Record last verified: 2017-02

Locations

US (1)