Cardiac Output Monitoring by ccNexfin© in Pregnant Women

Study Overview
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Brief Summary
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Variations of cardiac output are frequent in pregnant women during obstetrical procedures, and may participate to poor foetal outcomes through decrease of uteroplacental bloodflow. Thus, monitoring maternal cardiac output appears of major interest, as it would open the way to early initiation of hemodynamic supportive management. The ccNexfin© is a non-invasive hemodynamic monitoring device, whose relevance for continuous monitoring of cardiac output has been reported in a non-pregnant population. The hypothesis is that ccNexfin© gives acceptable measurement of maternal cardiac output in pregnant women.

Official Title
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Continuous Non-invasive Cardiac Output, an Evaluation of ccNexfin© in a Pregnant Population

Conditions
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Pregnancy

Intervention / Treatment
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* Device: cardiac output by ccNexfin ©


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Pregnancy > 32 weeks of amenorrhea Informed consent to participate to the study Health insurance Exclusion Criteria: Poor echogenicity for Transthoracic echocardiography Cardiopathy Difficulties to move Necessity of strict supine or lateral position Impossibility to receive information or to give inform consent to participate to the study Refusal to sign inform consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ccNexfin ©<br> | Device: cardiac output by ccNexfin ©<br>* Measurement of cardiac output by ccNexfin © comparatively to transthoracic echocardiography Subjects participating to the study will be simultaneously measured for cardiac output by ccNexfin © and transthoracic echocardiography. Echocardiographic measurements of cardiac output will be blinded to values measured by ccNexfin ©. For each participant, a first measurement of cardiac output will be performed in the supine position and then after 1 minute of strict left lateral position.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-class correlation coefficient between values of supine position cardiac output evaluated simultaneously by transthoracic echocardiography (measured in liters / minute) and ccNexfin © (measured in liters / minute) |  | 1 minute after positioning in supine position | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohen's Kappa coefficient between changes in maternal ejection volume observed from supine position to left lateral position, evaluated by transthoracic echocardiography (in %) and ccNexfin © (in %) respectively, at the 10% threshold of variation |  | Maternal ejection volume in supine position: 1 minute after positioning in supine position Maternal ejection volume in left lateral position: 1 minute after positioning in left lateral position | 
| Cohen's Kappa coefficient between changes in maternal cardiac output observed from supine position to left lateral position, assessed by transthoracic echocardiography (in %) and ccNexfin © (in %) respectively, at the 15% threshold of variation |  | Maternal cardiac output in supine position: 1 minute after positioning in supine position Maternal cardiac output in left lateral position: 1 minute after positioning in left lateral position | 
| Intra-class correlation coefficient between left lateral position cardiac output values assessed simultaneously by transthoracic echocardiography (measured in liters / minute) and ccNexfin © (measured in liters / minute) |  | 1 minute after positioning in left lateral position | 
| Pearson correlation coefficient between values of supine position maternal cardiac output evaluated by transthoracic echocardiography (measured in liters / minute) and ccNexfin © (measured in liters / minute), respectively |  | 1 minute after positioning in supine position | 
| Pearson correlation coefficient between values of left lateral position maternal cardiac output evaluated by transthoracic echocardiography (measured in liters / minute) and ccNexfin © (measured in liters / minute), respectively |  | 1 minute after positioning in left lateral position | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, ccNexfin©, cardiac output, hemodynamic, non-invasive monitoring