Cardiac Output Monitoring by ccNexfin© in Pregnant Women (CoNex)

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Device: cardiac output by ccNexfin ©

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital coeur poumon, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ccNexfin ©

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Alexandre GAUDET, MD, University Hospital, Lille

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2019
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; cardiac output; hemodynamic; non-invasive monitoring; ccNexfin©
• Other Study ID Numbers: 2017_54; 2018-A01089-46 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No