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NICOM in Pregnant Women With Heart Disease

NCT03616730 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-08-15

No results posted yet for this study

Summary

An accepted "gold standard" for hemodynamic monitoring in women with both healthy and diseased hearts is not currently available. Pregnancy is associated with significant hemodynamic changes, both during and following delivery, which can be even more profound in the structurally-abnormal heart. Clinical management of these women is based on surrogate markers of cardiac indices such as peripheral blood pressure, heart rate and oxygen saturation, rather than the use of invasive testing due to its associated complications. Echocardiography has largely replaced PAC in the obstetric population to measure cardiac output due to its non-invasive nature and good correlation with PAC18. However, its use is limited in the intrapartum period due to the need for clinical expertise in obtaining and interpreting the images. The proposed study has the potential to validate bio-reactance cardiac output monitoring using the NICOM against echocardiography for use in structurally normal and abnormal pregnant hearts in order to better drive goal-directed (specifically delivery mode) therapy through continuous hemodynamic monitoring during the second and third stages of labor, and 24 hours postpartum.

Conditions

  • Heart Diseases in Pregnancy
  • Congenital Heart Disease in Pregnancy

Interventions

DIAGNOSTIC_TEST

NICOM (non-invasive cardiac output monitor)

Transthoracic bio-reactance, or the non-invasive cardiac output measurement \[NICOMTM, Cheetah Medical Inc., Portland, OR\] system, is a new technique that is able to measure multiple hemodynamic parameters with four transdermal electrodes placed on the patients' thorax. It is based on frequency- and phase-modulation of the voltage signal measured in response to an applied transthoracic current. It has shown acceptable accuracy, precision and responsiveness for cardiac output monitoring in patients experiencing a wide-range of hemodynamic situations and is a FDA-approved device.

Sponsors & Collaborators

  • Saint Luke's Health System

    lead OTHER

Principal Investigators

  • Karen L Florio, DO · Saint Luke's Hospital of Kansas City/UMKC Assistant Professor, MFM Division

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-17
Primary Completion
2022-06-30
Completion
2022-08-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03616730 on ClinicalTrials.gov