NICOM in Pregnant Women With Heart Disease

August 11, 2022 updated by: Saint Luke's Health System

Validation of a Non-invasive Cardiac Output Monitor (NICOM) in Pregnant Women With Structural Heart Disease

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Major hormonal and hemodynamic changes occur in the cardiovascular system in pregnancy that can unmask and impact underlying cardiac disease. Cardiac output can rise by up to 50% throughout gestation, with an additional 30% rise intrapartum. This increase is multifactorial, owing to an increase of 50% in maternal blood volume during pregnancy, a decrease in afterload due to a decline in systemic vascular resistance and a rise in the maternal heart rate of up to 20 beats per minute. Cardiac output has been the most extensively studied physiologic parameter of cardiac performance during pregnancy, and is dependent on both heart rate and stroke volume. Most of the changes in cardiac output on pregnancy are a result of stroke volume. However, during the mid-second trimester, stroke volume plateaus while heart rate continues to rise, becoming the major contributor to cardiac output in the latter half of pregnancy. During labor, cardiac output is further increased by the autotransfusion of blood from the uterus during a uterine contraction and maternal expulsive efforts. This can lead to an increase of up to 500cc of blood within seconds into the systemic circulation, which can significantly impact cardiac output and stroke volume.

Following delivery, many of these cardiovascular changes reverse in the first 2 weeks postpartum with further normalization toward preconception values 3-12 months later. Women without heart disease adapt well and adverse events are generally rare. However, the stress induced by these antenatal changes can cause a patient with underlying disease to decompensate during the latter half of pregnancy and more specifically, intrapartum when these changes peak. Studies on maternal morbidity attributable to cardiac disease in the United States have shown the most likely time for an adverse cardiac event is intrapartum and immediately postpartum, owing to the drastic and acute changes in hemodynamic status during these time periods. Without an invasive monitor (PAC), hemodynamic monitoring during these time relies on surrogate markers such as blood pressure or heart rate.

There is relatively scarce data on continuous hemodynamic profiles in women with both congenital and acquired heart disease in pregnancy, specifically during labor. Previous literature on the use of invasive monitoring (PAC) during pregnancy have been performed only intermittently during the labor and postpartum process. However, the hemodynamic status during the second and third labor stages is not static and therefore the need for continuous evaluation cannot be underscored.

The increased morbidity associated with invasive monitoring limits the use of pulmonary artery catheters in the pregnant population and therefore a non-invasive way to obtain hemodynamic profiles in women with heart disease is desirable. The non-invasive cardiac output monitor (NICOM) is based on bio-reactance technology and is operator-independent, allowing negligible inter-observer variability in data collection and ease of use. Measurements of cardiac output and stroke volume are not dependent on the distance between the electrodes, which can significantly increase the accuracy of the results. It involves the application of four sensors on the thorax. Changes in aortic blood flow drive phase shifts of propagating waves which are detected by the sensors as the frequency changes. These changes correlate with instantaneous changes in blood volume and blood flow in the aorta. Bio-reactance has been validated against pulmonary artery catheters in non-pregnant populations which manifest various forms of hemodynamic instability and following cardiac surgery.

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. Its readings have been shown in multiple studies to correlate well with PAC in the non-pregnant population. It has shown acceptable accuracy, precision and responsiveness for cardiac output monitoring in patients experiencing a wide-range of hemodynamic situations. However, it has not been validated in the pregnant, structurally abnormal heart i.e. congenital cardiac disease, as this was exclusion criteria in the aforementioned studies. Establishing normative values during the second stage of labor utilizing the NICOM in women with congenital cardiac disease has the potential to be clinically useful in developing goal-directed management therapy for these women.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Both healthy pregnant women and pregnant women with a history of heart disease will be recruited to participate in our observational, non-inferiority trial comparing the cardiac output measurements obtained by two different modalities. Women in their first trimester will be approached to participate. Any woman with a history of either structural or acquired heart disease will be recruited into the study group as described above. Women with structurally normal hearts in the first trimester who meet the aforementioned inclusion criteria will also be recruited to participate as the control group.

Description

Inclusion Criteria:

  • CONTROL GROUP:
  • singleton pregnancy
  • > 18 years of age
  • enrolled in first trimester of pregnancy
  • planning delivery at Saint Luke's Hospital of Kansas City
  • STUDY GROUP:
  • history of either congenital or acquired heart disease
  • singleton pregnancy
  • > 18 years of age
  • enrolled in first trimester of pregnancy
  • planning delivery at Saint Luke's Hospital of Kansas City

Exclusion Criteria:

Control group:

  • no history of either acquired or congenital heart disease
  • no hypertension, diabetes, multiple gestations, preeclampsia, or autoimmune disease
  • no use of antihypertensive medications
  • inability to give informed consent

Study Group:

  • no hypertension, diabetes, multiple gestations, preeclampsia, autoimmune disease
  • inability to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Heart Disease in pregnancy group
Fifty women will be recruited with structurally and functionally abnormal hearts without a history of chronic hypertension, pre-gestational diabetes, multiple gestations, preeclampsia, autoimmune disease, and anyone with a history of cardiomyopathy but currently normal ejection fraction. Women who are unable to give informed consent will not be included.
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.
Control Group
Fifty women will be recruited with structurally normal hearts without a history of chronic hypertension, pre-gestational diabetes, multiple gestations, preeclampsia, autoimmune disease, and anyone with a history of cardiomyopathy but currently normal ejection fraction. Any woman on cardiac or antihypertensive medications (beta blockers, calcium channel blockers, hydralazine) will be excluded. Women who are unable to give informed consent will not be included.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-inferiority between NICOM and echocardiogram cardiac output measurements
Time Frame: 3 year recruitment
We will compare the cardiac output measurements obtained from the NICOM in each trimester with those obtained from the echocardiogram. We expect a mean percentage difference of < 30% between modalities.
3 year recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Luke's Health System

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2018

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

August 11, 2022

Study Registration Dates

First Submitted

July 25, 2018

First Submitted That Met QC Criteria

August 2, 2018

First Posted (Actual)

August 6, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2022

Last Update Submitted That Met QC Criteria

August 11, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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