Cardiac Output Monitoring by ccNexfin© in Pregnant Women

NCT03735043 | Completed

• 2 other identifiers: 2017_542018-A01089-46
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Pregnancy; ccNexfin©; cardiac output; hemodynamic; non-invasive monitoring

Outcome Measures

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)

  1 minute after positioning in supine position

Secondary Outcomes (5)

• 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

Study Arms (1)

ccNexfin ©

EXPERIMENTAL

Device: cardiac output by ccNexfin ©

Interventions

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.

ccNexfin ©

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnancy \> 32 weeks of amenorrhea
• Informed consent to participate to the study
• Health insurance

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital coeur poumon, CHU

Lille, France

Location

Related Publications (1)

• 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.

  PMID: 35927539 RESULT

Study Officials

• Alexandre GAUDET, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: November 8, 2018
• Study Start: July 2, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

FR (1)