Cardiac Output Monitoring by ccNexfin© in Pregnant Women

NCT ID: NCT03735043

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-02
• Study Completion Date: 2020-06-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ccNexfin ©

Group Type: EXPERIMENTAL

cardiac output by ccNexfin ©

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandre GAUDET, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hôpital coeur poumon, CHU

Lille, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 35927539 (View on PubMed)

Other Identifiers

2018-A01089-46

Identifier Type: OTHER

Identifier Source: secondary_id

2017_54

Identifier Type: -

Identifier Source: org_study_id