Non-invasive Haemodynamic Monitoring in Pregnancy

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03046784
• Other study ID #: darnord2017-01
• Status: Completed
• Start date: January 2017
• Est. completion date: May 31, 2017

Study information

• Verified date: April 2020
• Source: Hospital Nord
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• third trimester of pregnancy

• Non-labouring pregnant women

• accepting study

Exclusion Criteria:

• refusal of study

• first or second trimester of pregnancy

Related Conditions & MeSH terms

• Cardiac Output, High
• Haemodynamic Instability
• Pregnancy Related

Intervention

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.

Locations

Country	Name	City	State
France	Departement anesthesie reanimation hopital nord	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Nord

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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