Non-invasive Haemodynamic Monitoring in Pregnancy

Non-invasive Haemodynamic Monitoring in Pregnancy : Comparison Between Ultrasound and Nexfin Technology

This prospective and observational trial over 55 pregnant women (third trimester) compares non invasive haemodynamic monitoring using Nexfin technology and ultrasonography technic

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Cardiac Output, High; Haemodynamic Instability
• Intervention / Treatment: Other: haemodynamic evaluation

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13015
    • Departement anesthesie reanimation hopital nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Non-labouring term pregmant women in their third trimester

Description

Inclusion Criteria:

• third trimester of pregnancy
• Non-labouring pregnant women
• accepting study

Exclusion Criteria:

• refusal of study
• first or second trimester of pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant women in third trimester; Non-labouring pregnant women hospitalised during their third trimester of pregnancy has an haemodynamic evaluation with Nexfin technology and transthoracic cardiac ultrasonography. Evaluation is performed in two positions : dorsal decubitus and left lateral decubitus.	Other: haemodynamic evaluation; continous haemodynamic monitoring is performed with digital Nexfin captor in two positions. in the same time transthoracic cardiac ultrasonography is performed to calculate cardiac output using velocity time index of aortic outflow chamber.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac output measure	Cardiac output is measured with non-invasive digital Nexfin technology (ml/min) and compared with transthoracic echocardiographic measure of cardiac output (ml/min) used as reference. Echographic cardiac output (ml/min) is measured as the produce of cross sectional aera of left ventricular outflow track (cm²) multiplied by velocity time index (cm) multiplied by heart rate (beat/min)	30 minutes

Collaborators and Investigators

• Sponsor: Hospital Nord

Publications and helpful links

General Publications

• Lee SW, Khaw KS, Ngan Kee WD, Leung TY, Critchley LA. Haemodynamic effects from aortocaval compression at different angles of lateral tilt in non-labouring term pregnant women. Br J Anaesth. 2012 Dec;109(6):950-6. doi: 10.1093/bja/aes349. Epub 2012 Oct 11.
• Montenij LJ, Buhre WF, Jansen JR, Kruitwagen CL, de Waal EE. Methodology of method comparison studies evaluating the validity of cardiac output monitors: a stepwise approach and checklist. Br J Anaesth. 2016 Jun;116(6):750-8. doi: 10.1093/bja/aew094.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: January 27, 2017
• First Submitted That Met QC Criteria: February 6, 2017
• First Posted (Estimate): February 8, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiac Output, High
• Other Study ID Numbers: darnord2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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