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Completed

NCT Number: NCT03735043

Cardiac Output Monitoring by ccNexfin© in Pregnant Women

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.

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital coeur poumon, CHU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac output by ccNexfin ©

Device

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.

Primary outcomes

  1. 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)

    Time frame: 1 minute after positioning in supine position

Secondary outcomes

  1. 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

    Time frame: 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

  2. 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

    Time frame: 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

  3. 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)

    Time frame: 1 minute after positioning in left lateral position

  4. 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

    Time frame: 1 minute after positioning in supine position

  5. 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

    Time frame: 1 minute after positioning in left lateral position

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: CoNex

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 8, 2018
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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