Clinical trial NCT03735043: Cardiac Output Monitoring by ccNexfin© in Pregnant Women
Official title: Continuous Non-invasive Cardiac Output, an Evaluation of ccNexfin© in a Pregnant Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Pregnancy
ccNexfin©
cardiac output
hemodynamic
non-invasive monitoring
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 1 minute after positioning in supine position
Secondary outcomes:
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
measure: 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)
timeFrame: 1 minute after positioning in left lateral position
measure: 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
timeFrame: 1 minute after positioning in supine position
measure: 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
timeFrame: 1 minute after positioning in left lateral position
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital coeur poumon, CHU
Study officials:
affiliation: University Hospital, Lille
name: Alexandre GAUDET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonnin P, Constans B, Duhamel A, Kyheng M, Ducloy-Bouthors AS, Estevez MG, Tavernier B, Gaudet A. Accuracy and trending ability of finger plethysmographic cardiac output monitoring in late pregnancy. Can J Anaesth. 2022 Nov;69(11):1340-1348. doi: 10.1007/s12630-022-02297-y. Epub 2022 Aug 4.