Cardiac Output Monitoring by ccNexfin© in Pregnant Women

Pregnancy Clinical Trial

— CoNex  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03735043
• Other study ID #: 2017_54
• Secondary ID: 2018-A01089-46
• Status: Completed
• Phase: N/A
• Start date: July 2, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: March 2021
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Device:
• cardiac output by ccNexfin ©
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.

Locations

Country	Name	City	State
France	Hôpital coeur poumon, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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