Cardiac Output Monitoring by ccNexfin© in Pregnant Women

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Device: cardiac output by ccNexfin ©

• Registration Number: NCT03735043
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-08
• Study Start: 2019-07-02
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ccNexfin ©	cardiac output by ccNexfin ©	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Hôpital coeur poumon, CHU; 🇫🇷 Lille, France