NICOM in Pregnant Women With Heart Disease

Congenital Heart Disease in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03616730
• Other study ID #: 18-062
• Status: Terminated
• Start date: October 17, 2018
• Est. completion date: August 11, 2022

Study information

• Verified date: August 2022
• Source: Saint Luke's Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: August 11, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease in Pregnancy
• Heart Defects, Congenital
• Heart Diseases
• Heart Diseases in Pregnancy

Intervention

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.

Locations

Country	Name	City	State
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Saint Luke's Health System

Country where clinical trial is conducted

United States, 

References & Publications (19)

Canobbio MM, Warnes CA, Aboulhosn J, Connolly HM, Khanna A, Koos BJ, Mital S, Rose C, Silversides C, Stout K; American Heart Association Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Cardiovascular Disease in the Young; Council on Functional Genomics and Translational Biology; and Council on Quality of Care and Outcomes Research. Management of Pregnancy in Patients With Complex Congenital Heart Disease: A Scientific Statement for Healthcare Professionals From the American Heart Association. Circulation. 2017 Feb 21;135(8):e50-e87. doi: 10.1161/CIR.0000000000000458. Epub 2017 Jan 12. Review. — View Citation

Cornette J, Laker S, Jeffery B, Lombaard H, Alberts A, Rizopoulos D, Roos-Hesselink JW, Pattinson RC. Validation of maternal cardiac output assessed by transthoracic echocardiography against pulmonary artery catheterization in severely ill pregnant women: prospective comparative study and systematic review. Ultrasound Obstet Gynecol. 2017 Jan;49(1):25-31. doi: 10.1002/uog.16015. Epub 2016 Nov 28. Review. — View Citation

Critchley LA, Critchley JA. A meta-analysis of studies using bias and precision statistics to compare cardiac output measurement techniques. J Clin Monit Comput. 1999 Feb;15(2):85-91. — View Citation

Doherty A, El-Khuffash A, Monteith C, McSweeney L, Breatnach C, Kent E, Tully E, Malone F, Thornton P. Comparison of bioreactance and echocardiographic non-invasive cardiac output monitoring and myocardial function assessment in primagravida women. Br J Anaesth. 2017 Apr 1;118(4):527-532. doi: 10.1093/bja/aex045. — View Citation

Dyer RA, James MF. Maternal hemodynamic monitoring in obstetric anesthesia. Anesthesiology. 2008 Nov;109(5):765-7. doi: 10.1097/ALN.0b013e31818a3825. Review. — View Citation

Easterling TR, Watts DH, Schmucker BC, Benedetti TJ. Measurement of cardiac output during pregnancy: validation of Doppler technique and clinical observations in preeclampsia. Obstet Gynecol. 1987 Jun;69(6):845-50. — View Citation

Engoren M, Barbee D. Comparison of cardiac output determined by bioimpedance, thermodilution, and the Fick method. Am J Crit Care. 2005 Jan;14(1):40-5. — View Citation

Hunter S, Robson SC. Adaptation of the maternal heart in pregnancy. Br Heart J. 1992 Dec;68(6):540-3. Review. — View Citation

Keren H, Burkhoff D, Squara P. Evaluation of a noninvasive continuous cardiac output monitoring system based on thoracic bioreactance. Am J Physiol Heart Circ Physiol. 2007 Jul;293(1):H583-9. Epub 2007 Mar 23. — View Citation

Lee W, Rokey R, Cotton DB. Noninvasive maternal stroke volume and cardiac output determinations by pulsed Doppler echocardiography. Am J Obstet Gynecol. 1988 Mar;158(3 Pt 1):505-10. — View Citation

Mabie WC, DiSessa TG, Crocker LG, Sibai BM, Arheart KL. A longitudinal study of cardiac output in normal human pregnancy. Am J Obstet Gynecol. 1994 Mar;170(3):849-56. Review. — View Citation

McLaughlin K, Wright SP, Kingdom JCP, Parker JD. Clinical Validation of Non-Invasive Cardiac Output Monitoring in Healthy Pregnant Women. J Obstet Gynaecol Can. 2017 Nov;39(11):1008-1014. doi: 10.1016/j.jogc.2017.02.015. Epub 2017 Jul 18. — View Citation

Ohashi Y, Ibrahim H, Furtado L, Kingdom J, Carvalho JC. Non-invasive hemodynamic assessment of non-pregnant, healthy pregnant and preeclamptic women using bioreactance. [corrected]. Rev Bras Anestesiol. 2010 Nov-Dec;60(6):603-13, 335-40. doi: 10.1016/S0034-7094(10)70075-1. English, Portuguese, Spanish. Erratum in: Rev Bras Anestesiol. 2011 Jul-Aug;61(4):IX. — View Citation

Roberts LA, Ling HZ, Poon LC, Nicolaides KH, Kametas NA. Maternal hemodynamics, fetal biometry and Doppler indices in pregnancies followed up for suspected fetal growth restriction. Ultrasound Obstet Gynecol. 2018 Oct;52(4):507-514. doi: 10.1002/uog.19067. — View Citation

Sandham JD, Hull RD, Brant RF, Knox L, Pineo GF, Doig CJ, Laporta DP, Viner S, Passerini L, Devitt H, Kirby A, Jacka M; Canadian Critical Care Clinical Trials Group. A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients. N Engl J Med. 2003 Jan 2;348(1):5-14. — View Citation

Squara P, Denjean D, Estagnasie P, Brusset A, Dib JC, Dubois C. Noninvasive cardiac output monitoring (NICOM): a clinical validation. Intensive Care Med. 2007 Jul;33(7):1191-1194. doi: 10.1007/s00134-007-0640-0. Epub 2007 Apr 26. — View Citation

Velissaris D, Karamouzos V, Kotroni I, Pierrakos C, Karanikolas M. The Use of Pulmonary Artery Catheter in Sepsis Patients: A Literature Review. J Clin Med Res. 2016 Nov;8(11):769-776. Epub 2016 Sep 29. Review. — View Citation

Vinayagam D, Bowe S, Sheehan E, Thilaganathan B, Khalil A. Non-Invasive Haemodynamic Monitoring in Pregnancy: A Comparative Study Using Ultrasound and Bioreactance. Fetal Diagn Ther. 2017;41(4):273-282. doi: 10.1159/000446650. Epub 2016 Oct 6. — View Citation

Vinayagam D, Patey O, Thilaganathan B, Khalil A. Cardiac output assessment in pregnancy: comparison of two automated monitors with echocardiography. Ultrasound Obstet Gynecol. 2017 Jan;49(1):32-38. doi: 10.1002/uog.15915. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-inferiority between NICOM and echocardiogram cardiac output measurements	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

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